510(k) K254251

Device: InnovexView (GC146-17, GC150-20, GC155-23)
Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
510(k) number: K254251
Product code: HIH
Decision: Substantially Equivalent (SESE)
Decision date: 2026-02-26
Date received: 2025-12-29
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: N

Related Records

Applicant Contact

Contact: Shuwen Fan
Address: 3 & 4 Floor, #2 Bldg., 366 Huiqing Rd. East Zhangjiang High-Tech Park Shanghai CN 201201 201201

FDA Registration Numbers

3002808148
3007789561
2242464
3007200016
9680515
3012356141
1221485
3009350690
3011459664
3021023673
3006131984
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3015142721
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3010202439
2085947
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1418479
9611612
3040391040
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1225798
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3024021261
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1221826
2954783
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2243757
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3018094310
1320894
3029929134
9710457

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code HIH

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K254050	Manual Tissue Removal Device	Suzhou AcuVu Medical Technology Co., Ltd.	2026-05-15
K252793	ARMI® 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
K252012	SPY Cystoscope/Hysteroscope	Stryker Endoscopy	2025-07-18
K243382	RZ Resectoscope System	Rz Medizintechnik GmbH	2025-06-03
K240978	SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)	MacroLux Medical Technology Co., Ltd.	2024-08-16
K241987	Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)	Guangzhou Red Pine Medical Instrument Co., Ltd.	2024-08-02
K240401	ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)	Origyn Medical Technology (Hangzhou) Co., Ltd.	2024-07-26
K231260	HTx Disposable Hysteroscope System	Suzhou AcuVu Medical Technology Co., Ltd.	2024-03-05
K233635	SPY Cystoscope/Hysteroscope	Stryker Endoscopy	2024-02-12
K232003	Endoscopic Video Image Processor, Single-Use Video Hysteroscope	Guangzhou Red Pine Medical Instrument Co., Ltd.	2024-02-12
K233500	Benesta Tissue Removal Device	Caldera Medical, Inc.	2023-11-30
K223885	HOPKINS Telescopes	Karl Storz Endoscopy America, Inc.	2023-09-14
K223813	Aveta System 2.0	Meditrina, Inc.	2023-08-21
K223520	UNIDRIVE SIII System	Karl Storz-Endoscopy-America, Inc.	2023-04-27
K221557	Visera Hysterovideoscope Olympus HYF Type V	Olympus Medical Systems Corporation	2022-09-02