Retention Device, Suture
FDA product code KGS · Class I (low risk) · 21 CFR 878.4930 · General, Plastic Surgery
20510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Acufex Microsurgical, Inc. 4
- Concept, Inc. 2
- ETHICON, Inc. 2
- Richard'S Medical Equip., Inc. 1
- Biomet, Inc. 1
- Tek-Aid, Inc. 1
- Edwards Orthopaedics Div., Baxter Healthcare Corp. 1
- Dermacare 1
- Surgical Systems, Inc. 1
- The Hygenic Corp. 1
- Aesculap, Inc. 1
- Mitek Surgical Products, Inc. 1
- Smith & Nephew Endoscopy, Inc. 1
- Smith & Nephew, Inc. 1
- Accu-Speed, Incorporated 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030031 | Soft Tissue Anchoring WashersKGS · Traditional | Accu-Speed, Incorporated | 01/28/2003SE |
| K020480 | RBMKGS · Special | Smith & Nephew, Inc. | 03/12/2002SE |
| K964935 | Suture LockKGS · Traditional | Smith & Nephew Endoscopy, Inc. | 02/25/1997SE |
| K941740 | Acufex Rotator Cuff Fixation ButtonKGS · Traditional | Acufex Microsurgical, Inc. | 06/30/1995SE |
| K930675 | Mitek Cone WasherKGS · Traditional | Mitek Surgical Products, Inc. | 11/09/1993SE |
| K904435 | Ventrofil Tension Relief Suture SetKGS · Traditional | Aesculap, Inc. | 08/29/1991SE |
| K911225 | Tray DoughKGS · Traditional | The Hygenic Corp. | 04/17/1991SE |
| K904136 | Suture Tension Adjustment ReelKGS · Traditional | Surgical Systems, Inc. | 10/02/1990SE |
| K902001 | Surgical Retention BarKGS · Traditional | Acufex Microsurgical, Inc. | 05/09/1990SE |
| K896310 | Acufex Fixation Button; Retention Bar, WedgeKGS · Traditional | Acufex Microsurgical, Inc. | 11/20/1989SE |
| K893995 | Dermacare Tie HolderKGS · Traditional | Dermacare | 08/11/1989SE |
| K884565 | Acufex Fixation ButtonKGS · Traditional | Acufex Microsurgical, Inc. | 02/27/1989SE |
| K883299 | Suture Retention DeviceKGS · Traditional | Edwards Orthopaedics Div., Baxter Healthcare Corp. | 08/23/1988SE |
| K872608 | Hewson A.C.L. Guide SetKGS · Traditional | Concept, Inc. | 09/16/1987SE |
| K863570 | Le Veen Wound SplintKGS · Traditional | Tek-Aid, Inc. | 09/29/1986SE |
| K832138 | Biomer * Pledget Suture ButtressKGS · Traditional | ETHICON, Inc. | 05/23/1984SE |
| K813581 | Cruciate Ligament ButtonKGS · Traditional | Biomet, Inc. | 03/23/1982SE |
| K812819 | Ethicon* Surgical Sutures W/Compress BolKGS · Traditional | ETHICON, Inc. | 11/20/1981SE |
| K792004 | Hewson Ligament ButtonKGS · Traditional | Richard'S Medical Equip., Inc. | 11/05/1979SE |
| K771554 | Suture Retention ClampKGS · Traditional | Concept, Inc. | 09/02/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2330-2025 Class II | Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS…XXX | Drs Vascular, Inc | 05/16/2025Open, Classified |