K122983 is an FDA 510(k) clearance for the KSEA BIPOLAR ELECTRODE, a Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (Class II — Special Controls, product code HIN), submitted by KARL STORZ Endoscopy-America, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 26, 2013, 273 days after receiving the submission on September 26, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4150.
| 510(k) Number | K122983 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2012 |
| Decision Date | June 26, 2013 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIN — Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4150 |