K934971 is an FDA 510(k) clearance for the STERILE LAPAROTOMY SPONGES. This device is classified as a Gauze/sponge, Internal, X-ray Detectable (Class I - General Controls, product code GDY).
Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on February 7, 1994, 112 days after receiving the submission on October 18, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4450.
| 510(k) Number | K934971 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1993 |
| Decision Date | February 07, 1994 |
| Days to Decision | 112 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 |