510(k) K201756
- Device
- Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device For Fluent
- Applicant
- Stryker Sustainability Solutions
- 510(k) number
- K201756
- Product code
- HIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-09-25
- Date received
- 2020-06-29
- 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
- No
Applicant Contact#
- Contact
- Scott English
- Address
- 1810 W Dr.Ake Dr. Tempe AZ US 85283 85283
FDA Registration Numbers#
- 3003990090
- 3006131984
- 3014279513
- 9614434
- 3015042209
- 3025482817
- 3029929134
- 8010877
- 3013247477
- 3007699067
- 9710457
- 3016904853
- 3015139943
- 2020550
- 3007960282
- 2936485
- 3010707607
- 3016678045
- 3010202439
- 8010047
- 3035781529
- 3004361445
- 9611612
- 3021632375
- 9610617
- 3008494403
- 3007789561
- 3003790304
- 8010349
- 3011011193
- 3040391040
- 9610773
- 2183744
- 3033902430
- 3009420598
- 1220477
- 3030733800
- 3009217531
- 1221826
- 3011459664
- 2245304
- 3042158861
- 3015976667
- 3008386005
- 1649518
- 8043903
- 3008693678
- 3003542872
- 3011986317
- 1225798
- 3009746061
- 3015219237
- 3021246306
- 3015972753
- 3043226252
- 3015142721
- 3013557562
- 3014615697
- 3012322232
- 1064858
- 3007200016
- 3011050570
- 3002907620
- 9681753
- 3014644276
- 3016667340
- 3006787036
- 9611102
- 3002807310
- 1650907
- 3002808148
- 3027454635
- 9610595
- 3010132111
- 9680001
- 3004784537
- 3010273872
- 3035710892
- 3008837339
- 1221485
Source Documents#
Other 510(k) Records For Product Code HIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253020 | Strauss Surgical Resection Instruments | American Medical Endoscopy, Inc. | 2026-06-04 |
| 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 |
| K223885 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | 2023-09-14 |
| K223813 | Aveta System 2.0 | Meditrina, Inc. | 2023-08-21 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases