K112400 is an FDA 510(k) clearance for the SMARTSHEARS. This device is classified as a Cutter, Surgical (Class I - General Controls, product code FZT).
Submitted by Nuscience Consulting and Management Group, LLC (Fleming Island, US). The FDA issued a Cleared decision on September 12, 2011, 24 days after receiving the submission on August 19, 2011.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K112400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2011 |
| Decision Date | September 12, 2011 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZT — Cutter, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |