The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System.
| Device ID | K990144 |
| 510k Number | K990144 |
| Device Name: | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1340 WEST MIDDLEFIELD RD. Mountain View, CA 94043 |
| Contact | Michael Daniel |
| Correspondent | Michael Daniel INTUITIVE SURGICAL, INC. 1340 WEST MIDDLEFIELD RD. Mountain View, CA 94043 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 2000-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874112922 | K990144 | 000 |
| 00886874110058 | K990144 | 000 |
| 10886874111021 | K990144 | 000 |
| 10886874111007 | K990144 | 000 |