K253984
- 510(k) number
- K253984
- Device name
- Instrument Exit Point on Touch Surgery Aide
- Applicant
- Covidien, LLC MA · US
- Product code
- SFE — Endoscopic Video Imaging System / Software Component
- Decision date
- 2026-06-04
- Date received
- 2025-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K253984.pdf
Official FDA record: K253984
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.