The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Polyp Snare Net W/monopolar Cautery.
| Device ID | K926103 |
| 510k Number | K926103 |
| Device Name: | POLYP SNARE NET W/MONOPOLAR CAUTERY |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Contact | John Winstanley |
| Correspondent | John Winstanley UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-03 |
| Decision Date | 1993-09-23 |