K242923 is an FDA 510(k) clearance for the SimpleSnip Endoscopic Suture Cutter (SC500160). This device is classified as a Endoscopic Grasping/cutting Instrument, Non-powered (Class II - Special Controls, product code OCZ).
Submitted by Envision Endoscopy (Waltham, US). The FDA issued a Cleared decision on December 20, 2024, 87 days after receiving the submission on September 24, 2024.
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 | K242923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2024 |
| Decision Date | December 20, 2024 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |