K241638
- 510(k) number
- K241638
- Device name
- 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- NAY — System, Surgical, Computer Controlled Instrument
- Decision date
- 2024-09-10
- Date received
- 2024-06-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241638.pdf
Official FDA record: K241638
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.