K012632 is an FDA 510(k) clearance for the TOURNIQUET CUFF; PNEUMATIC TOURNIQUET, a Tourniquet, Pneumatic (Class I — General Controls, product code KCY), submitted by Medical Instruments Technology, Inc. (St. George, US). The FDA issued a Cleared decision on October 26, 2001, 74 days after receiving the submission on August 13, 2001. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5910.
| 510(k) Number | K012632 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 13, 2001 |
| Decision Date | October 26, 2001 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KCY — Tourniquet, Pneumatic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.5910 |