510(k) K173721 ยท NAY System, Surgical, Computer Controlled Instrument
SureForm 60 and SureForm 60 Reloads
| Applicant | Intuitive Surgical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 5, 2018 |
| Received | Dec 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173721
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2022 | Intuitive Surgical, Inc. da Vinici X da Vinci Xi Sureform 45 REF 480445
da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545
da Vinici X da Vinci Xi Sureform 60 REF 480460 Open, Classified |
NAY | None listed |
| Jul 1, 2019 | Intuitive Surgical, Inc. daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resectio Open, Classified |
GAG | None listed |
| Jul 1, 2019 | Intuitive Surgical, Inc. daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection Open, Classified |
GAG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.