The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for 5mm/8mm Harmonic Ace(tm) Curved Shears, Disposable Harmonic Ace(tm) Insert, Disposable Harmonic(tm) Curved Shears Insert.
| Device ID | K112584 |
| 510k Number | K112584 |
| Device Name: | 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 950 KIFER RD. Sunnyvale, CA 94086 -5206 |
| Contact | Kim T Servance |
| Correspondent | Kim T Servance 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 | 2011-09-06 |
| Decision Date | 2011-09-29 |
| Summary: | summary |