K132645 is an FDA 510(k) clearance for the THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES. This device is classified as a Retractor (Class I - General Controls, product code GAD).
Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 4, 2013, 42 days after receiving the submission on August 23, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K132645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2013 |
| Decision Date | October 04, 2013 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAD — Retractor |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |