Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable) +3 more— 510(k) K253892
Substantially EquivalentStrauss 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.
Summary
Strauss Surgical USA's record lists four Strauss Surgical Cystoscopes & Hysteroscopes HD-endoscope entries (STS-2040-302ASA, STS-2040-302AA, STS-2040-302BA, and STS-2040-302BSA), each 4 x 302 mm per the name. The device name is cut off partway through the fourth entry. All are filed under product code FAJ (Cystoscope And Accessories, Flexible/Rigid).
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Strauss Surgical USA filed from Doral, Florida. The record shows 133 calendar days from receipt to decision (December 4, 2025 to April 16, 2026).
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
- 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- K263075 — Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments
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- K253696 — CFlex Cystoscope - Standard Deflection (0570-0455) +2 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.