510(k) K233635

Device
SPY Cystoscope/Hysteroscope
Applicant
Stryker Endoscopy
510(k) number
K233635
Product code
HIH
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-12
Date received
2023-11-13
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
Michelle Ross
Address
5900 Optical Ct. San Jose CA US 95138 95138

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
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
K240401ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)Origyn Medical Technology (Hangzhou) Co., Ltd.2024-07-26
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
K233500Benesta Tissue Removal DeviceCaldera Medical, Inc.2023-11-30
K223885HOPKINS TelescopesKarl Storz Endoscopy America, Inc.2023-09-14
K223813Aveta System 2.0Meditrina, Inc.2023-08-21
K223520UNIDRIVE SIII SystemKarl Storz-Endoscopy-America, Inc.2023-04-27
K221557Visera Hysterovideoscope Olympus HYF Type VOlympus Medical Systems Corporation2022-09-02