FORCEPS, SUTURE, AUTO
FDA 510(k) clearance K772286 · decided 1977-12-20
Clearance details
- K-number
- K772286
- Device name
- FORCEPS, SUTURE, AUTO
- Applicant
- Hartmann Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-12-12
- Decision date
- 1977-12-20
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- GDO
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, 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 |
|---|---|---|
| UNICLIP SURGICAL CLIP APPLIER (K926199) | Unisurge, Inc. | 1993-04-20 |
| MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP (K890941) | United States Surgical, A Division of Tyco Healthc | 1989-04-07 |
| TOWEL CLIPS (K890159) | Dhason Brothers, Inc. | 1989-02-03 |
| SUTURE CLIP APPLIER/REMOVER (K890233) | Kinetic Medical Products | 1989-01-27 |
| DISPOSABLE MULTIPLE LIGATING CLIP (K820837) | ETHICON, Inc. | 1982-05-28 |
| ETHICON MULTIPLE LIGATING CLIP APPLIER (K812291) | ETHICON, Inc. | 1981-09-11 |
| HEMOSPENSER CARTRIDGE CAT. NO. 523500- (K792378) | Edward Weck, Inc. | 1979-12-06 |
| BAYONET HEIFETZ CLIP APPLIERS (K791845) | Edward Weck, Inc. | 1979-10-17 |
| SURGICAL DRAPE CLIP #201 (K790855) | C. Intl. | 1979-08-03 |
| 360 HEMOCLIP APPLIERS (K791157) | Edward Weck, Inc. | 1979-06-27 |
| REYNOLDS DOUBLE HEMOCLIP APPLIERS (K790990) | Edward Weck, Inc. | 1979-06-05 |
| LIGACLIP MULTIPLE CLIP APPLIER (K771412) | ETHICON, Inc. | 1977-11-28 |
Recalls involving this device
No recalls on record reference this clearance.