K803178 is an FDA 510(k) clearance for the ANSPACH MENISECTOMY KNIFE. This device is classified as a Curette, Surgical, General Use (Class I - General Controls, product code FZS).
Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1981, 59 days after receiving the submission on December 16, 1980.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K803178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1980 |
| Decision Date | February 13, 1981 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZS — Curette, Surgical, General Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |