510(k) K241987

Device: Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd.
510(k) number: K241987
Product code: HIH
Decision: Substantially Equivalent (SESE)
Decision date: 2024-08-02
Date received: 2024-07-08
Regulation: 884.1690
Classification name: Hysteroscope (And Accessories)
Medical specialty: Obstetrics/Gynecology
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Weihua Yang
Address: 12 F, #87 Luoxuan Ave., Guangzhou International Bioisland, H Guangzhou CN 510000 510000

FDA Registration Numbers

3002808148
3007789561
2242464
3007200016
9680515
3012356141
1221485
3009350690
3011459664
3021023673
3006131984
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2183744
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1216677
9612074
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3003724334
3015142721
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3010202439
2085947
3015219237
8010877
1064858
1418479
9611612
3040391040
8010510
3004361445
1225798
3007113251
3010132111
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9681753
1519132
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2953359
8043903
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3009217531
3006787036
3012263546
9611503
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2936485
3035781529
3021246306
3003542872
3014342096
1319639
8010418
1222780
3012322232
9611102
2245304
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3008386005
3012494290
3024021261
3007156625
3015042209
1221826
2954783
3014615697
3010273872
1220477
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1643817
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1219930
3016904853
2243757
3011543740
3015976667
3018094310
1320894
3029929134
9710457

Source Documents

510(k) summary PDF

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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