The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Gi-4000 Electrosurgical Generator.
| Device ID | K172805 |
| 510k Number | K172805 |
| Device Name: | Gi-4000 Electrosurgical Generator |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, OH 44060 |
| Contact | Carroll L. Martin |
| Correspondent | Carroll L. Martin United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, OH 44060 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2017-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995208124 | K172805 | 000 |
| 00724995180256 | K172805 | 000 |
| 00724995180263 | K172805 | 000 |
| 00724995227340 | K172805 | 000 |