K133736 is an FDA 510(k) clearance for the ENDOSCOPIC SUTURE CUTTER. This device is classified as a Endoscopic Grasping/cutting Instrument, Non-powered (Class II - Special Controls, product code OCZ).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on January 7, 2014, 29 days after receiving the submission on December 9, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope..
| 510(k) Number | K133736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2013 |
| Decision Date | January 07, 2014 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | OCZ - Endoscopic Grasping/cutting Instrument, Non-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope. |