The following data is part of a premarket notification filed by Genii, Inc. with the FDA for Genii Gi 4000 Electrosugical Generator.
| Device ID | K113265 |
| 510k Number | K113265 |
| Device Name: | GENII GI 4000 ELECTROSUGICAL GENERATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GENII, INC. 611 WEST 5TH FLOOR THIRD FLOOR Austin, TX 78701 |
| Contact | Julie Powell |
| Correspondent | Julie Powell GENII, INC. 611 WEST 5TH FLOOR THIRD FLOOR Austin, TX 78701 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-04 |
| Decision Date | 2012-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995209155 | K113265 | 000 |