← Back to catalogue

LapBag

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K171726Ref B11-1003ARef B21-1002Ref B21-1033Ref B21-1031Ref B12-1031Ref B12-1209Ref B21-1032Ref B11-1032Ref B12-1002Ref B12-1003Ref B12-1002ARef B11-1031Ref B12-1032Ref B21-1004Ref B11-1005Ref HB11-1003

by Sejong Medical Co., Ltd

Identity

Trade Name
Lapbag EUDAMEDFDA UDI
Generic Name
Tissue extraction bag FDA UDI
Device Name
Lapbag Metal Plus Type EUDAMED
Lapbag Metal Locking Type EUDAMED
Lapbag Non Metal Type EUDAMED
Lapbag Metal Type EUDAMED
Lapbag Non Metal Plus Type EUDAMED
Metal Handle Type EUDAMED
Model / Reference
B11-1005 EUDAMEDFDA UDI
B11-1003A EUDAMED
B21-1002 EUDAMED
B21-1033 EUDAMED
B21-1031 EUDAMED
B12-1031 EUDAMED
B12-1209 EUDAMED
B21-1032 EUDAMED
B11-1032 EUDAMED
B12-1002 EUDAMED
B12-1003 EUDAMED
B12-1002A EUDAMED
B11-1031 EUDAMED
B12-1032 EUDAMED
B21-1004 EUDAMED
HB11-1003 EUDAMED

Identifiers

Catalog Number
B11-1005 FDA UDI
Primary DI / UDI-DI
08806182216657 EUDAMEDFDA UDI
08806182206610 EUDAMED
08806182217364 EUDAMED
08806182200151 EUDAMED
08806182217432 EUDAMED
08806182206498 EUDAMED
08806182217203 EUDAMED
08806182200144 EUDAMED
08806182200168 EUDAMED
08806182217135 EUDAMED
08806182217142 EUDAMED
08806182206634 EUDAMED
08806182216695 EUDAMED
08806182206511 EUDAMED
08806182206566 EUDAMED
08806182207341 EUDAMED
Basic UDI-DI
B-08806182206610 EUDAMED
B-08806182217364 EUDAMED
B-08806182200151 EUDAMED
B-08806182217432 EUDAMED
B-08806182206498 EUDAMED
B-08806182217203 EUDAMED
B-08806182200144 EUDAMED
B-08806182200168 EUDAMED
B-08806182217135 EUDAMED
B-08806182217142 EUDAMED
B-08806182206634 EUDAMED
B-08806182216695 EUDAMED
B-08806182206511 EUDAMED
B-08806182206566 EUDAMED
B-08806182216657 EUDAMED
B-08806182207341 EUDAMED
510(k) Number
K171726 FDA 510(k)FDA UDI
FDA Product Code
GCJ FDA 510(k)FDA UDI
EMDN Code
S01010301 FLAT STERILISATION POUCHES, POLYETHYLENE EUDAMED
GMDN Term
Tissue extraction bag FDA UDI

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
Spain 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

The LapBag is a sterile, single-use specimen retrieval pouch designed for laparoscopic surgery. Classified under the product code GCJ, it is intended for collecting and containing biological specimens retrieved during minimally invasive procedures, ensuring safe and contained handling of tissue samples.

Supplied sterile and intended for single-use, the LapBag is used in laparoscopic settings where specimens such as gallbladder tissue or other excised materials are retrieved. It is authorized under FDA 510K clearance (K171726) and meets the requirements of the Medical Device Directive (MDD). The pouch is not intended for reuse or sterilization and must be handled in accordance with standard surgical specimen management protocols.

Frequently asked questions

What types of surgical procedures is the LapBag specifically designed for, and what kind of specimens can it contain?

The LapBag is designed for laparoscopic surgery, where it is used to collect and contain biological specimens retrieved during minimally invasive procedures. This includes specimens like gallbladder tissue or other excised materials, ensuring safe and contained handling during surgery.

Is the LapBag reusable, or is it meant for single-use only? How should it be handled after use?

The LapBag is explicitly intended for single-use only and must not be reused or sterilized. After use, it should be handled in accordance with standard surgical specimen management protocols to ensure proper disposal and compliance with medical waste guidelines.

What regulatory approvals does the LapBag have, and how does this affect its use in clinical settings?

The LapBag holds FDA 510K clearance (K171726) and complies with the Medical Device Directive (MDD). These approvals confirm that it meets regulatory standards for safety and performance, allowing its use in clinical settings where laparoscopic specimen retrieval is required.

How is the LapBag supplied, and what should clinicians consider when storing it before use?

The LapBag is supplied sterile and ready for immediate use in laparoscopic procedures. Clinicians should store it in a clean, dry environment, protected from contamination, and follow manufacturer guidelines to maintain sterility until the time of use.

Are there different sizes or models of the LapBag, or is it available in a single configuration?

The provided data does not specify multiple sizes or models for the LapBag, so it appears to be available in a standard configuration designed for general laparoscopic specimen retrieval. For exact specifications, refer to the manufacturer’s documentation.

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. Sources consulted: Sejong Lapbag Specimen Retrieval Pouch - medical-xprt.com, Sejong Medical Co., Ltd. Products, Sejong Medical - 세종메디칼, Sejong Medical Co., Ltd B11-1002 Lapbag - RevMed, Speciment Retrival Bag - LapBag by SeJong - Attikouris Medical

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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

Manufacturer

Manufacturer
Sejong Medical Co., Ltd
FDA Applicant
Sejong Medical Co., Ltd.

Sources (18)

  • FDA 510(k) K171726 24 fields · synced Sep 18, 2026
  • FDA UDI adcd1ca8-b389-47ad-a477-7eae97bf7229 34 fields · synced May 26, 2026
  • EUDAMED e012c617-19da-4f3d-a131-8fb6e9fbaf63 61 fields · synced Jul 9, 2026
  • EUDAMED 4013e473-4e98-4f48-ae84-c670e4d45273 61 fields · synced Jul 9, 2026
  • EUDAMED 03988eae-a0e3-4909-872c-85760d1f45e7 61 fields · synced Jul 9, 2026
  • EUDAMED 3989dd6b-b58a-4371-9561-1f91b512b903 61 fields · synced Jul 11, 2026
  • EUDAMED ab0cfd3d-609e-4264-b1a7-37314201e048 61 fields · synced Jul 12, 2026
  • EUDAMED 68ebd2c5-c8a6-4d88-91d2-0d68f101958b 61 fields · synced Jul 13, 2026
  • EUDAMED fe3b031d-df3a-4b41-bc2d-09e0198aeebd 61 fields · synced Jul 14, 2026
  • EUDAMED d478f99f-1de5-4922-8450-b470aa02c9d1 61 fields · synced Jul 15, 2026
  • EUDAMED f29c6da3-2c68-4a39-9f6f-ccbe881f59bc 61 fields · synced Jul 16, 2026
  • EUDAMED d2e233cc-5ff0-4c0c-8036-0de6d52a5543 61 fields · synced Jul 17, 2026
  • EUDAMED a976a8a1-9031-4a5c-bfe3-0b10c4e350c0 61 fields · synced Jul 19, 2026
  • EUDAMED 7c30a1f3-5b1d-4917-93f8-ba9bbfcd3851 61 fields · synced Jul 19, 2026
  • EUDAMED 35478196-09cb-4e03-91dc-a0985c8ce09d 61 fields · synced Jul 20, 2026
  • EUDAMED 25fa9ca9-19e8-464a-bcfb-361d03badb20 61 fields · synced Jul 21, 2026
  • EUDAMED 2bb4c167-fa1f-423a-85fa-81892e60da06 61 fields · synced Aug 3, 2026
  • EUDAMED 19c644fd-2863-4dea-a49c-c1160f6a9413 61 fields · synced Aug 3, 2026