K873555 is an FDA 510(k) clearance for the GORSK SPONGE CONTAINMENT SYSTEM. This device is classified as a Counter, Sponge, Surgical (Class I - General Controls, product code LWH).
Submitted by Gorsk, Inc. (Camarillo, US). The FDA issued a Cleared decision on October 23, 1987, 56 days after receiving the submission on August 28, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.2740.
| 510(k) Number | K873555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1987 |
| Decision Date | October 23, 1987 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | LWH — Counter, Sponge, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.2740 |