Data / Medical devices / United States / Acuvu Medical System Inc
Acuvu Medical System Inc: FDA-registered device maker in Los Altos, CA, United States, 1 510(k) clearance
Acuvu Medical System Inc is registered with the FDA (registration 3023365313) in Los Altos, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 15, 2026. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3023365313
- Address
- 4546 El Camino Real Suite 234, Los Altos, CA, United States, 94022
- Owner or operator
- Process Control Services (10083910)
- Roles
- Specification developer
- First device listed
- May 22, 2026
- Registered through
- 2026
- Brand names listed
- Manual Tissue Removal, Manual Tissue Removal Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hysteroscope (And Accessories) | HIH | 2 | 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 |
Compare with other makers
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.