Product code KGY
- Device name
- Bag, Intestine
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4100
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933085 | GOODMAN BANDAGE | Megadyne Medical Products, Inc. | 1993-12-23 |
| K913678 | TROCAR CATHETER | Medovations, Inc. | 1991-12-16 |
| K910914 | SURGICAL TISSUE POUCH | Cook Urological, Inc. | 1991-03-28 |
| K832318 | ISOLATION BAG 3M | 3M Company | 1983-10-31 |
| K801823 | BAND-AID BRAND TRICOT MESH BANDAGES | Johnson & Johnson Professionals, Inc. | 1980-08-20 |
| K801824 | BAND-AID BRAND FLEXIBLE FABRIC BANDAGE | Johnson & Johnson Professionals, Inc. | 1980-08-20 |
Related GUDID Devices#
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|---|---|---|---|
| 50707387071191 | 3M™ Steri-Drape™ | 3M COMPANY | 2026-04-17 |
| 20885632426602 | HALYARD | OWENS & MINOR DISTRIBUTION, INC. | 2026-02-05 |
| 10885632426605 | HALYARD | OWENS & MINOR DISTRIBUTION, INC. | 2026-02-05 |
| 20748426262599 | Medline-Microtek | Microtek Medical LLC | 2026-01-19 |
| 00888937027914 | LapSac | Coopersurgical, Inc. | 2025-09-03 |
| 00888937027907 | LapSac | Coopersurgical, Inc. | 2025-09-03 |
| 00888937027891 | LapSac | Coopersurgical, Inc. | 2025-09-03 |
| 00748426144037 | Medline-Microtek | Microtek Medical LLC | 2025-07-28 |
| 10192253067873 | CONVERTORS | Cardinal Health 200, LLC | 2025-06-30 |
| 16931918131153 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2025-06-20 |
| 00748426123568 | Cardinal Health | Microtek Medical LLC | 2024-09-26 |
| 16931918199078 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2023-07-20 |
| 00749756253956 | DeRoyal | DEROYAL INDUSTRIES, INC. | 2021-06-30 |
| 30707387030774 | 3M™ Steri-Drape™ | 3M COMPANY | 2018-09-24 |
| 14026704112538 | WECK | TELEFLEX INCORPORATED | 2018-09-21 |
| 14026704112521 | WECK | TELEFLEX INCORPORATED | 2018-09-21 |
| 14026704112514 | WECK | TELEFLEX INCORPORATED | 2018-09-21 |
| 05051223007753 | Secure Catch tissue retrieval pouch small | PURPLE SURGICAL INTERNATIONAL LIMITED | 2016-09-17 |
| 05051223025665 | Ultimate Endo Retrieval pouch | PURPLE SURGICAL INTERNATIONAL LIMITED | 2016-09-17 |
| 05051223022374 | Ultimate Endo Retrieval pouch | PURPLE SURGICAL INTERNATIONAL LIMITED | 2016-09-17 |
| 05051223008170 | Secure Catch Tissue Retrieval Pouch Medium with tail attachment | PURPLE SURGICAL INTERNATIONAL LIMITED | 2016-09-17 |
| 05051223008163 | Secure Catch Tissue Retrieval Pouch Small with tail attachment | PURPLE SURGICAL INTERNATIONAL LIMITED | 2016-09-17 |
| 05051223008057 | Ultimate Endo retrieval pouch | PURPLE SURGICAL INTERNATIONAL LIMITED | 2016-09-17 |
| 05051223007777 | Secure catch tissue retrieval pouch large | PURPLE SURGICAL INTERNATIONAL LIMITED | 2016-09-17 |
| 05051223007760 | Secure Catch tissue retrieval pouch medium | PURPLE SURGICAL INTERNATIONAL LIMITED | 2016-09-17 |
| 05051223000655 | Tissue Retrieval pouch large | PURPLE SURGICAL INTERNATIONAL LIMITED | 2016-09-17 |
| 05051223000648 | Tissue Retrieval pouch small | PURPLE SURGICAL INTERNATIONAL LIMITED | 2016-09-17 |
| 10630140942679 | CONVERTORS | Cardinal Health 200, LLC | 2016-07-08 |
| 10885380062797 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-28 |
| 50885380065765 | CONVERTORS | Cardinal Health 200, LLC | 2016-06-21 |