The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Single-site Medium-large Clip Applier, Single-site Cadiere Grasper, Single-site Fundus Grasper, Single-site Crocodile.
| Device ID | K120215 |
| 510k Number | K120215 |
| Device Name: | SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1450 Kifer Rd -- Sunnyvale, CA 94086 |
| Contact | Kim T Servance |
| Correspondent | Kim T Servance INTUITIVE SURGICAL, INC. 1450 Kifer Rd -- Sunnyvale, CA 94086 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-24 |
| Decision Date | 2012-04-30 |
| Summary: | summary |