Data / Medical devices / China / Innovex Medical Co., Ltd.
Innovex Medical Co., Ltd.: FDA-registered device maker in Shanghai, China, 1 510(k) clearance
Innovex Medical Co., Ltd. is registered with the FDA (registration 3032859397) in Shanghai, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 31, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032859397
- Address
- 2nd Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R. China 1st, 2nd Floor, No.14 Building and 3rd, 4th Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R, Shanghai, China, 201201
- Owner or operator
- INNOVEX MEDICAL CO., LTD. (10092290)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 20, 2024
- Registered through
- 2026
- Brand names listed
- Hoover Negative Pressure Access Sheath(IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250), OBSIDIAN(OBSI3515S and OBSI3815S), Single Use Grasping Forceps(IVX-GF1-1806A, IVX-GF1-1808A, IVX-GF1-1810A, IVX-GF1-1812A), Urological Sampler Sets (IVX-NB-150), Urological Stone Extraction Baskets(IVX-US-F1110, IVX-US-F1110S, IVX-US-F1110L);, Urological Stone Extraction Baskets(IVX-US-T0810, IVX-US-T0810S, IVX-US-T1110, IVX-US-T1110S)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dislodger, Stone, Flexible | FGO | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stylet, Ureteral | EYA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 31, 2025 | K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 | FED | Substantially Equivalent | Dornier Medtech America | accessdata.fda.gov |
Compare with other makers
- All makers of Dislodger, Stone, Flexible
- All makers of Stylet, Ureteral
- All makers of Bottle, Collection, Vacuum
- All makers of Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
Updated January 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.