K844177 is an FDA 510(k) clearance for the COSGROVE MITRAL VALVE RETRACTOR. This device is classified as a Retractor (Class I - General Controls, product code GAD).
Submitted by Kapp Surgical Instrument, Inc. (Cleveland, US). The FDA issued a Cleared decision on November 8, 1984, 14 days after receiving the submission on October 25, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K844177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1984 |
| Decision Date | November 08, 1984 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | GAD - Retractor |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |