The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Modification To Intuitive Surgical Stereo View Endoscopic System.
| Device ID | K001666 |
| 510k Number | K001666 |
| Device Name: | MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INTUITIVE SURGICAL, INC. 1340 WEST MIDDLEFIELD RD. Mountain View, CA 94043 |
| Contact | David Casal |
| Correspondent | David Casal INTUITIVE SURGICAL, INC. 1340 WEST MIDDLEFIELD RD. Mountain View, CA 94043 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-31 |
| Decision Date | 2000-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874110010 | K001666 | 000 |
| 00886874110003 | K001666 | 000 |