K070376 is an FDA 510(k) clearance for the CONMED LINVATEC 300W XENON LIGHT SOURCE, a Light Source, Endoscope, Xenon Arc (Class II — Special Controls, product code GCT), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on August 20, 2007, 193 days after receiving the submission on February 8, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K070376 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 08, 2007 |
| Decision Date | August 20, 2007 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GCT — Light Source, Endoscope, Xenon Arc |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |