510(k) K222839 ยท NAY System, Surgical, Computer Controlled Instrument
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 16, 2023 |
| Received | Sep 20, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K222839
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Intuitive Surgical, Inc. Intuitive 8 mm SureForm 30 Gray Reloads
Reference Numbers: 48230M-05 and 48230M-06 Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.