510(k) K223885

Device: HOPKINS Telescopes
Applicant: Karl Storz Endoscopy America, Inc.
510(k) number: K223885
Product code: HIH
Decision: Substantially Equivalent (SESE)
Decision date: 2023-09-14
Date received: 2022-12-27
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: Jordan Lydia Verla
Address: 2151 E. Grand Ave. El Segundo CA US 90245 90245

FDA Registration Numbers

3002808148
3007789561
2242464
3007200016
9680515
3012356141
1221485
3009350690
3011459664
3021023673
3006131984
3008693678
2183744
3006546082
1216677
9612074
3025482817
3003724334
3015142721
3011050570
3013557562
3007960282
3010202439
2085947
3015219237
8010877
1064858
1418479
9611612
3040391040
8010510
3004361445
1225798
3007113251
3010132111
3030733800
9681753
1519132
3002907620
3014279513
1649518
2953359
8043903
3027454635
3009217531
3006787036
3012263546
9611503
3011986317
3030153385
3002807310
2936485
3035781529
3021246306
3003542872
3014342096
1319639
8010418
1222780
3012322232
9611102
2245304
3021632375
3003990090
9515015
3015139943
3004784537
3021610866
3011011193
3017616393
3008386005
3012494290
3024021261
3007156625
3015042209
1221826
2954783
3014615697
3010273872
1220477

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code HIH

510(k)	Device	Applicant	Decision date
K254050	Manual Tissue Removal Device	Suzhou AcuVu Medical Technology Co., Ltd.	2026-05-15
K254251	InnovexView (GC146-17, GC150-20, GC155-23)	Shanghai AnQing Medical Instrument Co., Ltd.	2026-02-26
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
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