K844146 is an FDA 510(k) clearance for the TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW. This device is classified as a Pliers, Surgical (Class I - General Controls, product code HTC).
Submitted by Med-Tool, Inc. (Walker, US). The FDA issued a Cleared decision on November 20, 1984, 28 days after receiving the submission on October 23, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K844146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1984 |
| Decision Date | November 20, 1984 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HTC — Pliers, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |