K914083 is an FDA 510(k) clearance for the ICAN K DISSECTOR SPONGES. This device is classified as a Gauze/sponge, Internal, X-ray Detectable (Class I - General Controls, product code GDY).
Submitted by Icn Pharmaceuticals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on October 9, 1991, 28 days after receiving the submission on September 11, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4450.
| 510(k) Number | K914083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1991 |
| Decision Date | October 09, 1991 |
| Days to Decision | 28 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 |