K933994 is an FDA 510(k) clearance for the ARTHREX TOURNIQUET FOR LEG HOLDER. This device is classified as a Tourniquet, Pneumatic (Class I - General Controls, product code KCY).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 23, 1994, 218 days after receiving the submission on August 17, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5910.
| 510(k) Number | K933994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1993 |
| Decision Date | March 23, 1994 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | KCY — Tourniquet, Pneumatic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.5910 |