The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Bladeless Optical Obturators.
| Device ID | K152663 |
| 510k Number | K152663 |
| Device Name: | Bladeless Optical Obturators |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Contact | Vishal Kanani |
| Correspondent | Vishal Kanani INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-17 |
| Decision Date | 2015-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886874112691 | K152663 | 000 |
| 30886874112688 | K152663 | 000 |
| 10886874112530 | K152663 | 000 |
| 10886874112523 | K152663 | 000 |