K254251
- 510(k) number
- K254251
- Device name
- InnovexView (GC146-17, GC150-20, GC155-23)
- Applicant
- Shanghai AnQing Medical Instrument Co., Ltd. CN
- Product code
- HIH — Hysteroscope (And Accessories)
- Decision date
- 2026-02-26
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K254251.pdf
Official FDA record: K254251
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.