InnovexView (GC146-17, GC150-20, GC155-23)
FDA 510(k) K254251 · Shanghai AnQing Medical Instrument Co., Ltd.
510(k) numberK254251
Submission
- Device name
- InnovexView (GC146-17, GC150-20, GC155-23)
- Applicant
- Shanghai AnQing Medical Instrument Co., Ltd.
Shanghai, CN - Received
- December 29, 2025
- Decision date
- February 26, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K240401 | ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001…HIH · Traditional | Origyn Medical Technology (Hangzhou) Co., Ltd. | 07/26/2024SE |
More from Origyn Medical Technology (Hangzhou) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US…FGB · Special | 10/03/2025SE |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ · Special | 09/15/2025SE |
| K251752 | Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)EOQ · Traditional | 08/27/2025SE |
| K243497 | Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US…EOQ · Traditional | 05/29/2025SE |
| K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)FGB · Traditional | 04/11/2025SE |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)FBN · Traditional | 10/17/2023SE |
| K222162 | Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ · Traditional | 11/09/2022SE |
| K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)FGB · Special | 10/05/2022SE |
| K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model:…FGB · Traditional | 08/26/2022SE |
| K211169 | Bronchoscope SystemEOQ · Traditional | 11/24/2021SE |
Questions and answers
When was InnovexView (GC146-17, GC150-20, GC155-23) cleared by the FDA?
InnovexView (GC146-17, GC150-20, GC155-23) (K254251) received a 510(k) decision of Substantially Equivalent on February 26, 2026, 59 days after the submission was received.
What is the product code of K254251?
The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.