Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)— 510(k) K252598

Clearance details

Applicant

Shanghai AnQing Medical Instrument Co., Ltd.

Product code

Code FAJ

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2025-08-18

Decision date

2025-09-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Shanghai, CN

• K260649 — OES ELITE Cystoscope and Accessories +11 more2026-05-21
• K253696 — CFlex Cystoscope - Standard Deflection (0570-0455) +2 more2026-05-11
• K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable) +3 more2026-04-16
• K253905 — PrimeSight UltraView System2026-04-07
• K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments2026-03-27

• K254251 — InnovexView (GC146-17, GC150-20, GC155-23)2026-02-26
• K252806 — Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)2025-10-03
• K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)2025-08-27
• K243497 — Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US2025-05-29
• K243857 — Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)2025-04-11

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 →