The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Versapoint Electrosurgery System (scuba).
| Device ID | K994418 |
| 510k Number | K994418 |
| Device Name: | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) |
| Classification | Hysteroscope (and Accessories) |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Gregory Jones |
| Correspondent | Gregory Jones ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-29 |
| Decision Date | 2000-01-24 |
| Summary: | summary |