Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R) +1 more— 510(k) K242535
Substantially EquivalentHunan Vathin Medical Instrument Co., Ltd.
FDA 510(k) clearance K242535 for Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R) +1 more, Substantially Equivalent on 2024-12-18. Applicant: Hunan Vathin Medical Instrument Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd.
- 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
- Xiangtan, CN
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- K253905 — PrimeSight UltraView System
More clearances from Hunan Vathin Medical Instrument Co., Ltd.
view allAdverse 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.