K162365 is an FDA 510(k) clearance for the T-Cuff, a Tourniquet, Pneumatic (Class I — General Controls, product code KCY), submitted by Terumobct, Inc. (Lakewood, US). The FDA issued a Cleared decision on February 16, 2017, 177 days after receiving the submission on August 23, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5910.
| 510(k) Number | K162365 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 23, 2016 |
| Decision Date | February 16, 2017 |
| Days to Decision | 177 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 |