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510(k) K254251

InnovexView (GC146-17, GC150-20, GC155-23) by Shanghai AnQing Medical Instrument Co., Ltd. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2026
Date Received
December 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Shanghai AnQing Medical Instrument Co., Ltd.

  • K252806 — Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G- (October 3, 2025)
  • K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (September 15, 2025)
  • K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (August 27, 2025)
  • K243497 — Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, (May 29, 2025)
  • K243857 — Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) (April 11, 2025)
  • K231105 — Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) (October 17, 2023)
  • K222162 — Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (November 9, 2022)
  • K222737 — Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) (October 5, 2022)
  • K220159 — Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model (August 26, 2022)
  • K211169 — Bronchoscope System (November 24, 2021)

Other clearances for product code HIH

  • K252793 — ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysterosc (December 18, 2025)
  • K252012 — SPY Cystoscope/Hysteroscope (July 18, 2025)
  • K243382 — RZ Resectoscope System (June 3, 2025)
  • K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, H (August 16, 2024)
  • K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (August 2, 2024)
  • K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS- (July 26, 2024)
  • K231260 — HTx Disposable Hysteroscope System (March 5, 2024)
  • K233635 — SPY Cystoscope/Hysteroscope (February 12, 2024)
  • K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope (February 12, 2024)
  • K233500 — Benesta Tissue Removal Device (November 30, 2023)