The following data is part of a premarket notification filed by Gynecare, Inc. with the FDA for Versapoint Electrosurgery System (scuba).
| Device ID | K982738 |
| 510k Number | K982738 |
| Device Name: | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) |
| Classification | Hysteroscope (and Accessories) |
| Applicant | GYNECARE, INC. 235 CONSTITUTION DR. Menio Park, CA 94025 |
| Contact | Susan M Aloyan |
| Correspondent | Susan M Aloyan GYNECARE, INC. 235 CONSTITUTION DR. Menio Park, CA 94025 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-06 |
| Decision Date | 1999-03-01 |
| Summary: | summary |