K982142 is an FDA 510(k) clearance for the MOUNTABLE ENDOSCOPIC KNIFE. This device is classified as a Knife, Surgical (Class I - General Controls, product code EMF).
Submitted by A.M. Surgical, Inc. (Smithtown, US). The FDA issued a Cleared decision on December 30, 1998, 196 days after receiving the submission on June 17, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K982142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 1998 |
| Decision Date | December 30, 1998 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | EMF - Knife, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |