K242699
- 510(k) number
- K242699
- Device name
- Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)
- Applicant
- Opcom Medical, Inc. TW
- Product code
- FGB — Ureteroscope And Accessories, Flexible/Rigid
- Decision date
- 2025-05-28
- Date received
- 2024-09-09
- 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: K242699.pdf
Official FDA record: K242699
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.