Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments— 510(k) K263075
Substantially EquivalentStrauss Surgical USA
FDA 510(k) clearance K263075 for Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments, Substantially Equivalent on 2026-10-30. Applicant: Strauss Surgical USA. Device class: 2.
Clearance details
- Applicant
- Strauss Surgical USA
- Product code
- Product code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Doral, FL, US
Recent devices under product code FAJ
view all- K260649 — OES ELITE Cystoscope and Accessories +11 more
- K253696 — CFlex Cystoscope - Standard Deflection (0570-0455) +2 more
- K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable) +3 more
- K253905 — PrimeSight UltraView System
- K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments
Adverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.