510(k) K112584 ยท NAY System, Surgical, Computer Controlled Instrument
5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 29, 2011 |
| Received | Sep 6, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2019 | Intuitive Surgical, Inc. daVinci Harmonic ACE Curved Shears Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.