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CoralWell™ Single-use Ureteral Access Sheath - NS-1345B

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K250452Ref NS-1045BModel NS-0835B,NS-0840B,NS-0845B,NS-0855B,NS-0935B,NS-0940B,NS-0945B,NS-0955B,NS-1035B,NS-1040B,NS-1045B,NS-1055B,NS-1135B,NS-1140B,NS-1145B,NS-1155B,NS-1235B,NS-1240B,NS-1245B,NS-1255B,NS-1335B,NS-1340B,NS-1345B,NS-1355B,NS-1435B,NS-1440B,NS-1445B,NS-1455BRef NS-1040BRef NS-1055BRef NS-0945BRef NS-1445BRef NS-1440BRef NS-1135BRef NS-0845BRef NS-1355BRef NS-0935BRef NS-1435BRef NS-0955BRef NS-0855BRef NS-1255BRef NS-0835BRef NS-0940BRef NS-1155BRef NS-1140B

by MacroLux Medical Technology Co., Ltd.

Identity

Trade Name
CoralWell EUDAMEDFDA UDI
Generic Name
Ureteral introduction sheath FDA UDI
Device Name
Single-use Ureteral Access Sheath EUDAMED
Model / Reference
NS-1040B EUDAMEDFDA UDI
NS-1045B EUDAMEDFDA UDI
NS-1440B EUDAMEDFDA UDI
NS-1055B EUDAMEDFDA UDI
NS-1135B EUDAMEDFDA UDI
NS-1155B EUDAMEDFDA UDI
NS-1140B EUDAMEDFDA UDI
NS-0955B EUDAMEDFDA UDI
NS-0940B EUDAMEDFDA UDI
NS-1445B EUDAMEDFDA UDI
NS-0845B EUDAMEDFDA UDI
NS-1435B EUDAMEDFDA UDI
NS-0855B EUDAMEDFDA UDI
NS-1355B EUDAMEDFDA UDI
NS-0945B EUDAMEDFDA UDI
NS-0835B EUDAMEDFDA UDI
NS-1255B EUDAMEDFDA UDI
NS-0935B EUDAMEDFDA UDI
NS-0835B,NS-0840B,NS-0845B,NS-0855B,NS-0935B,NS-0940B,NS-0945B,NS-0955B,NS-1035B,NS-1040B,NS-1045B,NS-1055B,NS-1135B,NS-1140B,NS-1145B,NS-1155B,NS-1235B,NS-1240B,NS-1245B,NS-1255B,NS-1335B,NS-1340B,NS-1345B,NS-1355B,NS-1435B,NS-1440B,NS-1445B,NS-1455B EUDAMED

Identifiers

Primary DI / UDI-DI
06975339627652 EUDAMEDFDA UDI
06975339628222 EUDAMEDFDA UDI
06975339627812 EUDAMEDFDA UDI
06975339628239 EUDAMEDFDA UDI
06975339627683 EUDAMEDFDA UDI
06975339627713 EUDAMEDFDA UDI
06975339627690 EUDAMEDFDA UDI
06975339628192 EUDAMEDFDA UDI
06975339627614 EUDAMEDFDA UDI
06975339627829 EUDAMEDFDA UDI
06975339627676 EUDAMEDFDA UDI
06975339628147 EUDAMEDFDA UDI
06975339627638 EUDAMEDFDA UDI
06975339627805 EUDAMEDFDA UDI
06975339628154 EUDAMEDFDA UDI
06975339627799 EUDAMEDFDA UDI
06975339627621 EUDAMEDFDA UDI
06975339628123 EUDAMEDFDA UDI
06975339628314 EUDAMEDFDA UDI
06975339628376 EUDAMEDFDA UDI
06975339628246 EUDAMEDFDA UDI
06975339627607 EUDAMEDFDA UDI
06975339628277 EUDAMEDFDA UDI
06975339627591 EUDAMEDFDA UDI
06975339628383 EUDAMEDFDA UDI
Basic UDI-DI
697533962006MU EUDAMED
510(k) Number
K250452 FDA 510(k)FDA UDI
FDA Product Code
FED FDA 510(k)FDA UDI
EMDN Code
U0299 URETERAL CATHETERS - OTHER EUDAMED
GMDN Term
Ureteral introduction sheath FDA UDI
Models / Variants
NS-0835B FDA 510(k)FDA UDIEUDAMED
NS-0840B FDA 510(k)FDA UDIEUDAMED
NS-0845B FDA 510(k)FDA UDIEUDAMED
NS-0855B FDA 510(k)FDA UDIEUDAMED
NS-0935B FDA 510(k)FDA UDIEUDAMED
NS-0940B FDA 510(k)FDA UDIEUDAMED
NS-0945B FDA 510(k)FDA UDIEUDAMED
NS-0955B FDA 510(k)FDA UDIEUDAMED
NS-1035B FDA 510(k)FDA UDIEUDAMED
NS-1040B FDA 510(k)FDA UDIEUDAMED
NS-1045B FDA 510(k)FDA UDIEUDAMED
NS-1055B FDA 510(k)FDA UDIEUDAMED
NS-1135B FDA 510(k)FDA UDIEUDAMED
NS-1140B FDA 510(k)FDA UDIEUDAMED
NS-1145B FDA 510(k)FDA UDIEUDAMED
NS-1155B FDA 510(k)FDA UDIEUDAMED
NS-1235B FDA 510(k)FDA UDIEUDAMED
NS-1240B FDA 510(k)FDA UDIEUDAMED
NS-1245B FDA 510(k)FDA UDIEUDAMED
NS-1255B FDA 510(k)FDA UDIEUDAMED
NS-1335B FDA 510(k)FDA UDIEUDAMED
NS-1340B FDA 510(k)FDA UDIEUDAMED
NS-1345B FDA 510(k)FDA UDIEUDAMED
NS-1355B FDA 510(k)FDA UDIEUDAMED
NS-1435B FDA 510(k)FDA UDIEUDAMED
NS-1440B FDA 510(k)FDA UDIEUDAMED
NS-1445B FDA 510(k)FDA UDIEUDAMED
NS-1455B FDA 510(k)FDA UDIEUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)FDA UDI
Market of Registration
France EUDAMED
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIEUDAMED

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDIEUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

The CoralWell Single-use Ureteral Access Sheath is classified as an Endoscopic Access Overtube, designed to facilitate ureteral access procedures. It provides a protective pathway for instruments and catheters during interventions such as ureteroscopy, allowing for improved maneuverability and reduced trauma to the ureteral walls.

These single-use devices are intended for use in urological settings and are supplied sterile. Each model (e.g., NS-0835B) corresponds to specific sizes for compatibility with various ureteral anatomies. Authorized under FDA 510K and MDR, they adhere to regulatory standards for medical devices in gastroenterology and urology, ensuring compliance with safety and performance requirements.

Frequently asked questions

What is the CoralWell Single-use Ureteral Access Sheath primarily used for in clinical settings?

The CoralWell Single-use Ureteral Access Sheath is designed as an Endoscopic Access Overtube to facilitate ureteral access procedures, such as ureteroscopy. It provides a protective pathway for instruments and catheters, improving maneuverability and reducing trauma to the ureteral walls during interventions.

Are these devices reusable or intended for single-use, and how should they be handled post-procedure?

The CoralWell Ureteral Access Sheath is explicitly labeled as single-use only. After a procedure, the device should be discarded in accordance with standard medical waste protocols to prevent cross-contamination and ensure patient safety.

How do I determine the correct size for a patient’s anatomy when selecting a CoralWell model?

Each CoralWell model (e.g., NS-0835B) corresponds to specific sizes tailored for compatibility with different ureteral anatomies. The manufacturer provides sizing guidelines—check the product documentation or consult with the supplier to match the patient’s anatomy to the appropriate model.

Are these devices sterile upon arrival, and if so, what precautions should be taken during storage?

Yes, the CoralWell Single-use Ureteral Access Sheath is supplied sterile. Store the devices in their original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, to maintain sterility until use. Avoid opening the packaging until immediately before the procedure.

What regulatory pathways have been followed for this device, and which agencies have authorized its use?

The CoralWell Single-use Ureteral Access Sheath has been authorized under FDA 510K and the EU Medical Device Regulation (MDR). These pathways confirm compliance with safety and performance standards for endoscopic access devices in urology and gastroenterology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
MacroLux Medical Technology Co., Ltd.

Sources (51)

  • FDA 510(k) K250452 24 fields · synced Oct 5, 2026
  • FDA UDI 88c22354-b5a3-4ad6-9371-7cdf5038f8a0 33 fields · synced May 29, 2026
  • FDA UDI dc82f304-e60a-4493-843b-da3a723063dd 33 fields · synced May 29, 2026
  • FDA UDI 5703b32c-9a93-4638-b847-fbee129f2893 33 fields · synced May 29, 2026
  • FDA UDI 0069bdda-e70b-4f96-be52-bb2d3a542d1b 33 fields · synced May 29, 2026
  • FDA UDI 1a5bb5ae-3bc6-4ab7-bfe8-6dba1617a115 33 fields · synced May 29, 2026
  • FDA UDI eb2ac74b-b67e-4216-ac7f-8eefa6423051 33 fields · synced May 29, 2026
  • FDA UDI b6d47e3c-355e-4cbd-b2f5-14931e4ab871 33 fields · synced May 29, 2026
  • FDA UDI 26f8f7a2-5c50-47f4-a89d-aff09ce3191d 33 fields · synced May 30, 2026
  • FDA UDI 25005637-4d51-44eb-a03f-c318329905db 33 fields · synced May 30, 2026
  • FDA UDI 2ffd1dc3-5ca7-4168-9282-3211fb637368 33 fields · synced May 30, 2026
  • FDA UDI ba369f63-e27b-4333-be5f-d9684801ca0f 33 fields · synced May 30, 2026
  • FDA UDI 63d7d552-6e8f-41b7-a76d-7a4856c57b5d 33 fields · synced May 30, 2026
  • FDA UDI 71004a1b-45b0-4b96-9833-822b364f8baf 33 fields · synced May 30, 2026
  • FDA UDI 37336783-7de4-4f8a-aa16-605692ff566f 33 fields · synced May 30, 2026
  • FDA UDI a02461cd-274b-433d-a7d5-990f96d5a9ac 33 fields · synced May 30, 2026
  • FDA UDI b44dd7f7-447d-41e0-a930-54093b489392 33 fields · synced May 30, 2026
  • FDA UDI d6297aa3-bafa-4d5c-b065-ae19106d5e64 33 fields · synced May 30, 2026
  • FDA UDI 9fa45297-6306-48a1-a003-7eaf851b611a 33 fields · synced May 30, 2026
  • FDA UDI c61e7040-1cc8-48d9-a5ed-f330d3a7f6ce 33 fields · synced May 30, 2026
  • FDA UDI 2d13ca33-1919-4c9e-9fe6-1cca4270bfe4 33 fields · synced May 30, 2026
  • FDA UDI 2304b4d3-3966-4100-8b12-fb2152c19fe3 33 fields · synced May 30, 2026
  • FDA UDI 5a97dcb2-193f-4529-82b4-4b0de5289d65 33 fields · synced May 30, 2026
  • FDA UDI 4249bd0b-b4de-402a-a779-aeb24027ede7 33 fields · synced May 30, 2026
  • FDA UDI 2f358e49-156f-4853-88e5-00ea26a40699 33 fields · synced May 30, 2026
  • FDA UDI 183cbf30-e110-4f5a-93c7-90098c7f9fd2 33 fields · synced May 30, 2026
  • EUDAMED 57f2affa-a590-4b3a-bcb7-873c27bfc05c 61 fields · synced Jul 9, 2026
  • EUDAMED 4aefa7ee-00f5-4ac2-b95d-43fb880a131e 61 fields · synced Jul 9, 2026
  • EUDAMED 0d723dfd-96ca-4f61-909c-8cf8ba2b070d 61 fields · synced Jul 9, 2026
  • EUDAMED f74d31c3-51ae-4330-a33f-c7f5a72842b1 61 fields · synced Jul 10, 2026
  • EUDAMED 13eee59a-9335-4fa3-924a-97de6dd7e09e 61 fields · synced Jul 10, 2026
  • EUDAMED c2749423-16c6-4ab6-87ea-dcafae057cad 61 fields · synced Jul 11, 2026
  • EUDAMED 448fdb13-9f28-4cb7-b47b-a1d389f7a4b2 61 fields · synced Jul 11, 2026
  • EUDAMED 71542ad2-e17b-42c7-a84e-7b602b328c4e 61 fields · synced Jul 13, 2026
  • EUDAMED 3f67ddb8-037e-4383-bd4b-43e3ba652101 61 fields · synced Jul 13, 2026
  • EUDAMED ba1f416a-137f-4ca1-8df3-841d7cf41746 61 fields · synced Jul 14, 2026
  • EUDAMED f8985d13-d4f7-4985-9941-9c5de76b7650 61 fields · synced Jul 14, 2026
  • EUDAMED 66ac0d7a-1032-407d-ab00-3d363d08bcf8 61 fields · synced Jul 15, 2026
  • EUDAMED 51de7edc-7ef0-4fcc-9fbc-bd5ccb4d59ed 61 fields · synced Jul 18, 2026
  • EUDAMED 2fa517e5-f0ad-42da-ae6b-796f04d07160 61 fields · synced Jul 22, 2026
  • EUDAMED f9b6e0a7-470d-4342-b57f-d68ea8b19f49 61 fields · synced Jul 24, 2026
  • EUDAMED b4f3f014-91c9-4074-af7c-c194d0d63618 61 fields · synced Jul 25, 2026
  • EUDAMED 6e2edebc-a9aa-4353-b1d7-78c9609bff81 61 fields · synced Jul 27, 2026
  • EUDAMED 7e78fe6e-5253-429c-a690-e8e590b10c61 61 fields · synced Jul 28, 2026
  • EUDAMED d6601b66-8df2-4871-ba22-ca36c245c123 61 fields · synced Jul 28, 2026
  • EUDAMED 329cd206-0beb-46ec-bb41-216009a98595 61 fields · synced Jul 29, 2026
  • EUDAMED 3a3096cb-179f-4638-a196-1d7c756c075f 61 fields · synced Jul 29, 2026
  • EUDAMED 4304a58f-c142-4958-a1e2-e393187d777a 61 fields · synced Aug 2, 2026
  • EUDAMED 77b5fe07-ce0a-4508-8e96-027ec3266f3c 61 fields · synced Sep 18, 2026
  • EUDAMED 301bbe4b-9eba-4b7a-b7a2-a7009765392a 61 fields · synced Oct 5, 2026
  • EUDAMED 8566292d-e9e8-4d06-a1db-1892319ec2b4 61 fields · synced Oct 5, 2026