Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
FDA 510(k) K191335 · Corinth Medtech, Inc.
510(k) numberK191335
Submission
- Device name
- 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.
Cupertino, CA, US - Received
- May 17, 2019
- Decision date
- June 6, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIH – Hysteroscope (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254294 | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A…HIH · Traditional | Zhejiang Geyi Medical Instrument Co., Ltd. | 09/08/2026SE |
| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)HIH · Traditional | Axora Medical, Inc. | 08/18/2026SE |
| K253020 | Strauss Surgical Resection InstrumentsHIH · Traditional | American Medical Endoscopy, Inc. | 06/04/2026SE |
| K254050 | Manual Tissue Removal DeviceHIH · Traditional | Suzhou AcuVu Medical Technology Co., Ltd. | 05/15/2026SE |
| K254251 | InnovexView (GC146-17, GC150-20, GC155-23)HIH · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 02/26/2026SE |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope…HIH · Traditional | Jiangsu Jiyuan Medical Technology Co., Ltd. | 12/18/2025SE |
| K252012 | SPY Cystoscope/HysteroscopeHIH · Special | Stryker Endoscopy | 07/18/2025SE |
| K243382 | RZ Resectoscope SystemHIH · Traditional | Rz Medizintechnik GmbH | 06/03/2025SE |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…HIH · Traditional | MacroLux Medical Technology Co., Ltd. | 08/16/2024SE |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)HIH · Special | Guangzhou Red Pine Medical Instrument Co., Ltd. | 08/02/2024SE |
More from Guangzhou Red Pine Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K230205 | Veloxion SystemFJL · Special | 02/24/2023SE |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…FJL · Special | 06/13/2019SE |
| K190113 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…HIH · Traditional | 04/24/2019SE |
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion…FJL · Traditional | 03/15/2019SE |
| K180752 | Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid…HIH · Traditional | 07/25/2018SE |
| K162979 | Veloxion SystemFJL · Traditional | 03/24/2017SE |
Questions and answers
When was Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags cleared by the FDA?
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (K191335) received a 510(k) decision of Substantially Equivalent on June 6, 2019, 20 days after the submission was received.
What is the product code of K191335?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.