510(k) K190113
- Device
- Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- Applicant
- Corinth MedTech, Inc.
- 510(k) number
- K190113
- Product code
- HIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-04-24
- Date received
- 2019-01-24
- 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
- Sandeep Saboo
- Address
- 1601 S. De Anza Blvd., Suite 200 Cupertino CA US 95014 95014
FDA Registration Numbers#
- 1222780
- 3024021261
- 1221485
- 3035710892
- 3007200016
- 9617070
- 2954783
- 1519132
- 2243757
- 1222313
- 2244478
- 3008494403
- 1216677
- 3035781529
- 3007113251
- 8010047
- 3011050570
- 3012356141
- 3011986317
- 1047843
- 3010202439
- 3002907620
- 3018094310
- 2936485
- 3004784537
- 1319639
- 3021023673
- 2245304
- 3003724334
- 3007699067
- 3042158861
- 3003990090
- 3016667340
- 1064858
- 9611102
- 1219930
- 3004361445
- 1220477
- 9614434
- 3010273872
- 1056128
- 3040391040
- 3003790304
- 9610773
- 3029929134
- 1221826
- 9611503
- 3012263546
- 3008386005
- 3025482817
- 2085947
- 3004111573
- 3015142721
- 2953359
- 1643817
- 3015972753
- 1649518
- 9681753
- 3002808148
- 2020550
- 9710457
- 3014644276
- 3007960282
- 3011011193
- 3013944123
- 8010418
- 2242464
- 9610595
- 3043226252
- 8010349
- 1650907
- 3007789561
- 3014407293
- 9515015
- 3016678045
- 3006546082
- 3010399422
- 3017616393
- 9680001
- 3030733800
Source Documents#
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 |
| 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 |
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