510(k) K211997 ยท NAY System, Surgical, Computer Controlled Instrument
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 10, 2021 |
| Received | Jun 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211997
| 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 |
| Nov 30, 2022 | Intuitive Surgical, Inc. INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530
INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M
INTUITIVE Da Vinci 8mm SureForm 3 Open, Classified |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.