The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Monopolar Curved Scissors Tip Cover Accessory.
| Device ID | K112263 |
| 510k Number | K112263 |
| Device Name: | MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Contact | Brandon Hansen |
| Correspondent | Brandon Hansen INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-08 |
| Decision Date | 2011-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886874111045 | K112263 | 000 |