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allFlex Ureteral Catheters, Krait Ureteral Catheters

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K220730Ref UC-AO7Model allFlex Ureteral Catheters (Closed Tip,Open Tip), allFlex Ureteral Catheters Cone Tip,allFlex Ureteral Catheters (Angle Closed Tip,Angle Open Tip),allFlex Ureteral Catheters Open Tapered Tip,Krait Ureteral Catheters (Closed Tip, Open Tip)Ref UC-AO6Ref K-UC-O5Ref K-UC-R6Ref K-UC-R5Ref K-UC-O4Ref K-UC-O6Ref UC-O6Ref UC-AR5

by Allwin Medical Devices, Inc.

Identity

Trade Name
allFlex Ureteral Catheters EUDAMED
Krait Ureteral Catheters EUDAMED
Krait FDA UDI
Generic Name
Ureteral catheter FDA UDI
Device Name
URETERAL CATHETERS EUDAMED
Krait Ureteral Catheter Closed Tip 6F, 70cm FDA UDI
Krait Ureteral Catheter Closed Tip 5F, 70cm FDA UDI
Krait Ureteral Catheter Open Tip 6F, 70 cm FDA UDI
Krait Ureteral Catheter Open Tip 5F, 70 cm FDA UDI
Krait Ureteral Catheter Open Tip 4F, 70cm FDA UDI
Model / Reference
allFlex Ureteral Catheters (Closed Tip,Open Tip), allFlex Ureteral Catheters Cone Tip,allFlex Ureteral Catheters (Angle Closed Tip,Angle Open Tip),allFlex Ureteral Catheters Open Tapered Tip,Krait Ureteral Catheters (Closed Tip, Open Tip) EUDAMED
UC-AO7 EUDAMED
UC-AO6 EUDAMED
K-UC-O5 EUDAMED
K-UC-R6 EUDAMED
K-UC-R5 EUDAMED
K-UC-O4 EUDAMED
K-UC-O6 EUDAMED
UC-O6 EUDAMED
UC-AR5 EUDAMED
Krait Ureteral Catheter Closed Tip 6F, 70cm FDA UDI
Krait Ureteral Catheter Closed Tip 5F, 70cm FDA UDI
Krait Ureteral Catheter Open Tip FDA UDI
Krait Ureteral Catheter Open Tip 4F, 70cm FDA UDI
Description
Krait Ureteral Catheter Closed Tip 6F, 70cm FDA UDI
Krait Ureteral Catheter Closed Tip 5F, 70cm FDA UDI
Krait Ureteral Catheter Open Tip 6F, 70 cm FDA UDI
Krait Ureteral Catheter Open Tip 5F, 70 cm FDA UDI
Krait Ureteral Catheter Open Tip 4F, 70cm FDA UDI

Identifiers

Catalog Number
K-UC-R6 FDA UDI
K-UC-R5 FDA UDI
K-UC-O6 FDA UDI
K-UC-O5 FDA UDI
KUC-O4 FDA UDI
Primary DI / UDI-DI
00819374023177 EUDAMEDFDA UDI
00819374022408 EUDAMEDFDA UDI
00812261013312 EUDAMEDFDA UDI
00812261016023 EUDAMEDFDA UDI
00819374020404 EUDAMEDFDA UDI
00812261013145 EUDAMED
00812261013138 EUDAMED
00812261013039 EUDAMED
00819374023122 EUDAMED
Basic UDI-DI
081226101UCT017TQ EUDAMED
510(k) Number
K220730 FDA 510(k)FDA UDI
FDA Product Code
KOD FDA 510(k)FDA UDI
EMDN Code
U0299 URETERAL CATHETERS - OTHER EUDAMED
GMDN Term
Ureteral catheter FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 876.5130 FDA 510(k)
Regulation Number
876.5130 FDA 510(k)FDA UDI
Market of Registration
Romania EUDAMED
Netherlands EUDAMED
Czechia 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 UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

No

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

Yes

FDA UDI

The allFlex Ureteral Catheters and Krait Ureteral Catheters are flexible, tubular medical devices designed for urinary drainage. These catheters are classified as urological catheters and are intended for insertion into the ureter to facilitate the passage of urine from the kidney to the bladder, aiding in the management of urinary obstruction or post-surgical drainage.

These catheters are supplied as single-use devices and are regulated under FDA 510K and MDR authorizations. They are available in various sizes and reference codes, as listed in the OpenFDA database, and are intended for use in clinical settings such as urology and gastroenterology procedures. Sterility and MRI safety are not specified in the provided data, but they are typically handled under aseptic conditions and stored according to manufacturer guidelines.

Frequently asked questions

What clinical specialties are these catheters primarily used in, and why are they relevant for those fields?

The allFlex and Krait Ureteral Catheters are primarily used in urology and gastroenterology procedures. These specialties rely on them for urinary drainage, particularly in cases of ureteral obstruction or post-surgical drainage, where maintaining patency of urine flow from the kidney to the bladder is critical. The flexible design and specialized construction make them suitable for navigating the ureteral anatomy, which is essential in both urological interventions (e.g., stenting, stone management) and endoscopic procedures (e.g., ERCP-related drainage).

Are these catheters reusable, or are they intended for single-use only? How does this affect their clinical workflow?

The allFlex and Krait Ureteral Catheters are explicitly supplied as single-use devices. This design choice ensures patient safety by eliminating cross-contamination risks and reduces the need for reprocessing, streamlining clinical workflows. Single-use catheters also minimize the risk of infection and mechanical failure from repeated use, which is particularly important in sterile procedures like ureteral drainage.

How many sizes or models are available, and what factors should clinicians consider when selecting one?

The catheters come in multiple sizes and reference codes, as listed in the OpenFDA database (e.g., 1000121056, 3008806809, etc.). Selection depends on the patient’s anatomy, the specific clinical indication (e.g., pediatric vs. adult), and procedural requirements. For example, narrower diameters may be needed for pediatric patients or delicate ureteral navigation, while larger sizes might accommodate post-surgical drainage or obstructions. Always refer to the manufacturer’s sizing guidelines for precise matching.

What storage or handling instructions should be followed to maintain their integrity before use?

While the provided data does not specify sterility or MRI safety details, standard practice for single-use catheters like these includes storing them in a clean, dry environment away from direct sunlight or extreme temperatures. They should be kept in their original packaging until use to preserve sterility and prevent contamination. Always follow the manufacturer’s instructions for unpacking and handling to ensure the device remains uncontaminated and functional.

What regulatory pathway was followed for these catheters, and what does that mean for their use in clinical settings?

The allFlex and Krait Ureteral Catheters were cleared through the FDA 510(k) pathway and comply with MDR (Medical Device Regulation) standards. This means they have undergone a premarket review to demonstrate substantial equivalence to legally marketed devices, ensuring they meet safety and performance requirements. Clinicians can rely on their regulatory clearance as evidence of compliance with U.S. and EU standards, though local guidelines should always be consulted for specific procedural use.

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

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Manufacturer

Manufacturer
Allwin Medical Devices, Inc.

Sources (15)

  • FDA 510(k) K220730 24 fields · synced Sep 18, 2026
  • FDA UDI 81b28193-e7cb-4bda-8aff-c8813567c1bb 36 fields · synced May 30, 2026
  • FDA UDI d99f5c89-33cd-40d2-9015-c5ef49daab61 36 fields · synced May 30, 2026
  • FDA UDI 5c639140-0abb-4d0f-86d5-107c9b75e61c 36 fields · synced May 30, 2026
  • FDA UDI ccd9986f-30be-45c0-80f4-253ba3816c75 36 fields · synced May 30, 2026
  • FDA UDI 32986805-d362-4578-9d04-8f66e2f8bec4 36 fields · synced May 30, 2026
  • EUDAMED 8e9949f2-3de2-41db-a7c1-b24ea23176ba 61 fields · synced Jul 9, 2026
  • EUDAMED 91936fe2-ec9a-4450-80d2-769fed73a33f 61 fields · synced Jul 9, 2026
  • EUDAMED 7603d1d5-c45b-4abb-9ec6-4d4820a0f76c 61 fields · synced Jul 11, 2026
  • EUDAMED 4f6e0143-5b67-4d9c-95f1-b7355ced0ed0 61 fields · synced Jul 14, 2026
  • EUDAMED 3b0dec3c-bb92-4d7a-81ab-92e8b464300b 61 fields · synced Jul 17, 2026
  • EUDAMED b1fb20c1-5857-451c-9469-b1a3739df5e3 61 fields · synced Jul 21, 2026
  • EUDAMED 6fdc400e-b21f-4d46-b8df-76996724c35e 61 fields · synced Aug 2, 2026
  • EUDAMED 474b9b56-a620-4698-a9df-7d267af43c8b 61 fields · synced Aug 4, 2026
  • EUDAMED 0cbf0bbd-f3aa-48ac-91dc-ca40701a7315 61 fields · synced Aug 4, 2026