K872807 is an FDA 510(k) clearance for the NON-WOVEN TRACHEOTOMY SPONGE. 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. (Lynn, US). The FDA issued a Cleared decision on August 4, 1987, 21 days after receiving the submission on July 14, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4450.
| 510(k) Number | K872807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1987 |
| Decision Date | August 04, 1987 |
| Days to Decision | 21 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 |