The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Endoscopic Suture Cutter.
| Device ID | K133736 |
| 510k Number | K133736 |
| Device Name: | ENDOSCOPIC SUTURE CUTTER |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Eric Maynard |
| Correspondent | Eric Maynard UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-09 |
| Decision Date | 2014-01-07 |