K123553 is an FDA 510(k) clearance for the ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM. This device is classified as a Tourniquet, Pneumatic (Class I - General Controls, product code KCY).
Submitted by Zimmer, Inc. (Indianpolis, US). The FDA issued a Cleared decision on August 9, 2013, 263 days after receiving the submission on November 19, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5910.
| 510(k) Number | K123553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2012 |
| Decision Date | August 09, 2013 |
| Days to Decision | 263 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 |