SUTURE LOCK
FDA 510(k) clearance K964935 · decided 1997-02-25
Clearance details
- K-number
- K964935
- Device name
- SUTURE LOCK
- Applicant
- Smith & Nephew Endoscopy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-10
- Decision date
- 1997-02-25
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- KGS
- Device class
- 1
- Regulation number
- 878.4930
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SOFT TISSUE ANCHORING WASHERS (K030031) | Accu-Speed, Incorporated | 2003-01-28 |
| RBM (K020480) | Smith & Nephew, Inc. | 2002-03-12 |
| ACUFEX ROTATOR CUFF FIXATION BUTTON (K941740) | Acufex Microsurgical, Inc. | 1995-06-30 |
| MITEK CONE WASHER (K930675) | Mitek Surgical Products, Inc. | 1993-11-09 |
| VENTROFIL TENSION RELIEF SUTURE SET (K904435) | Aesculap, Inc. | 1991-08-29 |
| TRAY DOUGH (K911225) | The Hygenic Corp. | 1991-04-17 |
| SUTURE TENSION ADJUSTMENT REEL (K904136) | Surgical Systems, Inc. | 1990-10-02 |
| SURGICAL RETENTION BAR (K902001) | Acufex Microsurgical, Inc. | 1990-05-09 |
| ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE (K896310) | Acufex Microsurgical, Inc. | 1989-11-20 |
| DERMACARE TIE HOLDER (K893995) | Dermacare | 1989-08-11 |
| ACUFEX FIXATION BUTTON (K884565) | Acufex Microsurgical, Inc. | 1989-02-27 |
| SUTURE RETENTION DEVICE (K883299) | Edwards Orthopaedics Div., Baxter Healthcare Corp. | 1988-08-23 |
Recalls involving this device
No recalls on record reference this clearance.