K090583 is an FDA 510(k) clearance for the ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165. This device is classified as a Forceps, Biopsy, Electric (Class II - Special Controls, product code KGE).
Submitted by Apollo Endosurgery, Inc. (Austin, US). The FDA issued a Cleared decision on June 26, 2009, 114 days after receiving the submission on March 4, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K090583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2009 |
| Decision Date | June 26, 2009 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KGE - Forceps, Biopsy, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |