K854714 is an FDA 510(k) clearance for the X-RAY DETECTABLE COTTON BALLS. This device is classified as a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY).
Submitted by American Silk Sutures, Inc. (Ledyard, US). The FDA issued a Cleared decision on December 17, 1985, 25 days after receiving the submission on November 22, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4450.
| 510(k) Number | K854714 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1985 |
| Decision Date | December 17, 1985 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDY — Gauze/sponge, Internal, X-ray Detectable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4450 |