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 |