LIGACLIP MULTIPLE CLIP APPLIER
FDA 510(k) clearance K771412 · decided 1977-11-28
Clearance details
- K-number
- K771412
- Device name
- LIGACLIP MULTIPLE CLIP APPLIER
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-08-01
- Decision date
- 1977-11-28
- Days to decision
- 119 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
- 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 |
|---|---|---|
| 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 |
| FORCEPS, SUTURE, AUTO (K772286) | Hartmann Group, Inc. | 1977-12-20 |
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 |