ETHICON EXTERNAL FIXATION WIRE
FDA 510(k) clearance K821178 · decided 1983-06-11
Clearance details
- K-number
- K821178
- Device name
- ETHICON EXTERNAL FIXATION WIRE
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-27
- Decision date
- 1983-06-11
- Days to decision
- 410 days
- Clearance type
- Traditional
- Product code
- FYI
- Device class
- 1
- Regulation number
- 878.3250
- 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 |
|---|---|---|
| OMEGA BIVALVE NASAL SPLINTS (K871073) | Omega Silicone, Inc. | 1987-05-11 |
| STRAITH NASAL SPLINT (K801072) | Surgical Technology Laboratories, Inc. | 1980-06-17 |
| CONPHAR O.R. HEAD COVER-STERILE (K792106) | Conphar, Inc. | 1979-11-05 |
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 |