The following data is part of a premarket notification filed by Intuitive Surgical, Inc. with the FDA for Is4000 8mm Harmonic Ace Curved Shears.
| Device ID | K143132 |
| 510k Number | K143132 |
| Device Name: | IS4000 8mm Harmonic ACE Curved Shears |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 -5206 |
| Contact | Earle Canty |
| Correspondent | Nadine Nasr INTUITIVE SURGICAL, INC. 1266 KIFER ROAD Sunnyvale, CA 94086 -5206 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-31 |
| Decision Date | 2015-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886874112738 | K143132 | 000 |