FDA.reportPublic FDA data

510(k) K240401

Device
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
Applicant
Origyn Medical Technology (Hangzhou) Co., Ltd.
510(k) number
K240401
Product code
HIH
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-26
Date received
2024-02-09
Regulation
884.1690
Classification name
Hysteroscope (And Accessories)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Cheng Xinyuan
Address
Rm.310,3f,Bldg. 6,#688,Bin'An Rd., Changhe St., Binjiang Dist, Hangzhou, Zhejiang Hangzhou CN

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HIH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)Karl Storz SE & CO. KG2026-09-25
K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG2026-09-18
K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.2026-09-08
K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.2026-08-18
K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.2026-06-04
K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.2026-05-15
K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.2026-02-26
K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.2025-12-18
K252012SPY Cystoscope/HysteroscopeStryker Endoscopy2025-07-18
K243382RZ Resectoscope SystemRz Medizintechnik GmbH2025-06-03
K240978SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)MacroLux Medical Technology Co., Ltd.2024-08-16
K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)Guangzhou Red Pine Medical Instrument Co., Ltd.2024-08-02
K231260HTx Disposable Hysteroscope SystemSuzhou AcuVu Medical Technology Co., Ltd.2024-03-05
K232003Endoscopic Video Image Processor, Single-Use Video HysteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.2024-02-12
K233635SPY Cystoscope/HysteroscopeStryker Endoscopy2024-02-12