K030194 is an FDA 510(k) clearance for the XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by The Olympus Optical Co. (Melville, US). The FDA issued a Cleared decision on March 24, 2003, 62 days after receiving the submission on January 21, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K030194 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 21, 2003 |
| Decision Date | March 24, 2003 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |