ETHICON* SURGICAL SUTURES W/COMPRESS BOL
FDA 510(k) clearance K812819 · decided 1981-11-20
Clearance details
- K-number
- K812819
- Device name
- ETHICON* SURGICAL SUTURES W/COMPRESS BOL
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-07
- Decision date
- 1981-11-20
- Days to decision
- 44 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
- Mchenry, IL, 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 |
| SUTURE LOCK (K964935) | Smith & Nephew Endoscopy, Inc. | 1997-02-25 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |