510(k) K252012
- Device
- SPY Cystoscope/Hysteroscope
- Applicant
- Stryker Endoscopy
- 510(k) number
- K252012
- Product code
- HIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-18
- Date received
- 2025-06-27
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Irina Glazkova
- Address
- 5900 Optical Ct. San Jose CA US 95138 95138
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
- 3015972753
- 1047843
- 1650907
- 9610617
- 1643817
- 3009420598
- 3028536560
- 8010047
- 3010707607
- 9610595
- 1223490
- 9610773
- 3015512350
- 3043236281
- 3014644276
- 3004111573
- 9617070
- 9680001
- 3007699067
- 3016667340
- 3013944123
- 9680718
- 3008837339
- 9614434
- 3003790304
- 1222313
- 3013247477
- 3033902430
- 3042158861
- 2244478
- 3035387162
- 3016678045
- 2020550
- 3043226252
- 3009746061
- 3007829657
- 3006330030
- 9710641
- 3008494403
- 1056128
- 3014407293
- 8010349
- 3035710892
- 3010399422
- 1219930
- 3016904853
- 2243757
- 3011543740
- 3015976667
- 3018094310
- 1320894
- 3029929134
- 9710457
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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 |
| 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 |