K260271
- 510(k) number
- K260271
- Device name
- Strauss Surgical cystoscope, hysteroscope and accessories Instruments
- Applicant
- American Medical Endoscopy, Inc. FL · US
- Product code
- FAJ — Cystoscope And Accessories, Flexible/Rigid
- Decision date
- 2026-03-27
- Date received
- 2026-01-28
- 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: K260271.pdf
Official FDA record: K260271
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.