K931198 is an FDA 510(k) clearance for the UNIQUET. This device is classified as a Tourniquet, Nonpneumatic (Class I - General Controls, product code GAX).
Submitted by Icat Systems (San Leandro, US). The FDA issued a Cleared decision on September 1, 1993, 176 days after receiving the submission on March 9, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5900.
| 510(k) Number | K931198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1993 |
| Decision Date | September 01, 1993 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAX — Tourniquet, Nonpneumatic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.5900 |