K253978
- 510(k) number
- K253978
- Device name
- Universal Seal (5-12 mm)
- Applicant
- Intuitive Surgical, Inc. CA · US
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2026-02-24
- Date received
- 2025-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253978.pdf
Official FDA record: K253978
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.