K080133 is an FDA 510(k) clearance for the MOUNTABLE ENDOSCOPIC BLADE. 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 March 13, 2008, 55 days after receiving the submission on January 18, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K080133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2008 |
| Decision Date | March 13, 2008 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | EMF - Knife, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |