Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable) +3 more— 510(k) K253892

Name: FDA 510(k) clearance K253892
Creator: U.S. Food and Drug Administration
Published: 2026-04-16

Substantially Equivalent

Strauss Surgical USA

FDA 510(k) clearance K253892 for Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable) +3 more, Substantially Equivalent on 2026-04-16. Applicant: Strauss Surgical USA. Device class: 2.

Clearance details

Device name as filed: Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,
Applicant: Strauss Surgical USA
Product code: Code FAJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-12-04
Decision date: 2026-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Doral, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.