K103726 is an FDA 510(k) clearance for the JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS. This device is classified as a Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (Class II - Special Controls, product code KNF).
Submitted by Integra LifeSciences Corporation (York, US). The FDA issued a Cleared decision on February 8, 2012, 413 days after receiving the submission on December 22, 2010.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K103726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2010 |
| Decision Date | February 08, 2012 |
| Days to Decision | 413 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNF — Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4160 |