K955599 is an FDA 510(k) clearance for the STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE. This device is classified as a Gauze/sponge, Internal, X-ray Detectable (Class I - General Controls, product code GDY).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on February 22, 1996, 76 days after receiving the submission on December 8, 1995.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4450.
| 510(k) Number | K955599 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1995 |
| Decision Date | February 22, 1996 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDY — Gauze/sponge, Internal, X-ray Detectable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4450 |