The following data is part of a premarket notification filed by Gyne-tech Instrument Corp. with the FDA for Electrosurgical Generator Model Esu100/250/550.
| Device ID | K914367 |
| 510k Number | K914367 |
| Device Name: | ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | GYNE-TECH INSTRUMENT CORP. 1111 CHESTNUT ST. Burbank, CA 91506 |
| Contact | J.kermit Floyd |
| Correspondent | J.kermit Floyd GYNE-TECH INSTRUMENT CORP. 1111 CHESTNUT ST. Burbank, CA 91506 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-01 |
| Decision Date | 1992-04-28 |