Data / Medical devices / China / Suzhou Acuvu Medical Technology Co., Ltd.
Suzhou Acuvu Medical Technology Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 3 510(k) clearances
Suzhou Acuvu Medical Technology Co., Ltd. is registered with the FDA (registration 3021610866) in Suzhou Jiangsu, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021610866
- Address
- B1-212, Bio-Nano Park, 218 Xinghu St. Suzhou Industrial Park, Suzhou Jiangsu, China, 215125
- Owner or operator
- Process Control Services (10083910)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 29, 2021
- Registered through
- 2026
- Brand names listed
- Disposable Hysteroscope System, Disposable Hysteroscope accessory, HTx Disposable Hysteroscope System, Hysteroscope accessories, Manual Tissue Removal, Manual Tissue Removal Device, eStar - reusable surgical instruments
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Forceps | HTD | 1 | Specification developer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Manufacturer | accessdata.fda.gov |
| Hysteroscope Accessories | NWW | 1 | Specification developer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 15, 2026 | K254050 | Manual Tissue Removal Device | HIH | Substantially Equivalent | Suzhou AcuVu Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 5, 2024 | K231260 | HTx Disposable Hysteroscope System | HIH | Substantially Equivalent | Suzhou AcuVu Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 15, 2021 | K211227 | HTx Disposable Hysteroscope System | HIH | Substantially Equivalent | Acuvu, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Scissors, General, Surgical
- All makers of Forceps
- All makers of Hysteroscope (And Accessories)
- All makers of Hysteroscope Accessories
Updated May 15, 2026. 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.