K821178 is an FDA 510(k) clearance for the ETHICON EXTERNAL FIXATION WIRE. This device is classified as a Appliance, Facial Fracture, External (Class I - General Controls, product code FYI).
Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on June 11, 1983, 410 days after receiving the submission on April 27, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3250.
| 510(k) Number | K821178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1982 |
| Decision Date | June 11, 1983 |
| Days to Decision | 410 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FYI — Appliance, Facial Fracture, External |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.3250 |