HIH — Hysteroscope (And Accessories) Class II

FDA Device Classification

Classification Details

Product Code
HIH
Device Class
Class II
Regulation Number
884.1690
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K254251shanghai anqing medical instrument coInnovexView (GC146-17, GC150-20, GC155-23)February 26, 2026
K252793jiangsu jiyuan medical technology coARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use HysteroscDecember 18, 2025
K252012stryker endoscopySPY Cystoscope/HysteroscopeJuly 18, 2025
K243382rz medizintechnikRZ Resectoscope SystemJune 3, 2025
K240978macrolux medical technology coSeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HAugust 16, 2024
K241987guangzhou red pine medical instrument coSingle-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)August 2, 2024
K240401origyn medical technology (hangzhou) coClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-July 26, 2024
K231260suzhou acuvu medical technology coHTx Disposable Hysteroscope SystemMarch 5, 2024
K232003guangzhou red pine medical instrument coEndoscopic Video Image Processor, Single-Use Video HysteroscopeFebruary 12, 2024
K233635stryker endoscopySPY Cystoscope/HysteroscopeFebruary 12, 2024
K233500caldera medicalBenesta Tissue Removal DeviceNovember 30, 2023
K223885karl storz endoscopy americaHOPKINS TelescopesSeptember 14, 2023
K223813meditrinaAveta System 2.0August 21, 2023
K223520karl storz-endoscopy-americaUNIDRIVE SIII SystemApril 27, 2023
K221557olympus medical systems corporationVisera Hysterovideoscope Olympus HYF Type VSeptember 2, 2022
K213171meditrinaAveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta DisposableMay 26, 2022
K213207olympus winter and ibeSheath, Stopcock AccessoryDecember 22, 2021
K202445hysterovueHystero-V HysteroscopeNovember 23, 2021
K210270jiangsu jiyuan medical technology coMedical Endoscope Image Processing SystemOctober 1, 2021
K211227acuvuHTx Disposable Hysteroscope SystemSeptember 15, 2021