510(k) clearance
Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments
- 510(k) number
- K263075
- Applicant
- Strauss Surgical USA
- Decision date
- Oct 30, 2026
- Date received
- Sep 2, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FAJ
- Device type
- Cystoscope And Accessories, Flexible/Rigid
- Device class
- Class II
- Regulation
- 21 CFR 876.1500
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Doral, FL, US