The following data is part of a premarket notification filed by Envision Surgical System, Inc. with the FDA for Envision Arthroscopy System.
| Device ID | K942081 |
| 510k Number | K942081 |
| Device Name: | ENVISION ARTHROSCOPY SYSTEM |
| Classification | Arthroscope |
| Applicant | ENVISION SURGICAL SYSTEM, INC. 1047 ELWELL COURT Palo Alto, CA 94303 |
| Contact | Phil Olsen |
| Correspondent | Phil Olsen ENVISION SURGICAL SYSTEM, INC. 1047 ELWELL COURT Palo Alto, CA 94303 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-29 |
| Decision Date | 1994-11-09 |