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 | K080155 |
| 510k Number | K080155 |
| Device Name: | MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Contact | Michael H Yramategui |
| Correspondent | Michael H Yramategui INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-23 |
| Decision Date | 2008-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886874113141 | K080155 | 000 |
| 00886874111734 | K080155 | 000 |
| 00886874110430 | K080155 | 000 |
| 00886874110423 | K080155 | 000 |
| 00886874110034 | K080155 | 000 |
| 00886874110027 | K080155 | 000 |