K243596
- 510(k) number
- K243596
- Device name
- da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- GAG — Stapler, Surgical
- Decision date
- 2025-03-10
- Date received
- 2024-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K243596.pdf
Official FDA record: K243596
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.