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 | K192265 |
| 510k Number | K192265 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-21 |
| Decision Date | 2020-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995180284 | K192265 | 000 |
| 00724995180263 | K192265 | 000 |
| 00724995209131 | K192265 | 000 |
| 00724995209124 | K192265 | 000 |
| 00724995209117 | K192265 | 000 |