K261249
- 510(k) number
- K261249
- Device name
- Universal Seal (5-12 mm)
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2026-07-14
- Date received
- 2026-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261249.pdf
Official FDA record: K261249
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.