Data / Medical devices / India / Ace Medical Devices Pvt. Ltd
Ace Medical Devices Pvt. Ltd: FDA-registered device maker in PUNE Maharashtra, India, 1 510(k) clearance
Ace Medical Devices Pvt. Ltd is registered with the FDA (registration 3011987935) in PUNE Maharashtra, India. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 11, 2016. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011987935
- Address
- 401A, Gera 77, East Avenue, Kalyani Nagar, PUNE Maharashtra, India, 411 006
- Owner or operator
- Ace Medical Devices Pvt Ltd (10050230)
- Roles
- Specification developer
- First device listed
- October 23, 2015
- Registered through
- 2026
- Brand names listed
- ACE BVac, ACE Electrosurgical Resection and Vaporization Electrodes Series
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Electrosurgical, Active, Urological | FAS | 2 | Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Specification developer | accessdata.fda.gov |
| Evacuator, Bladder, Manually Operated | FFD | 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 |
|---|---|---|---|---|---|---|
| July 11, 2016 | K153055 | ACE Electrosurgical Resection and Vaporization Electrodes Series | GEI | Substantially Equivalent | Ace Medical Devices Pvt. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Electrode, Electrosurgical, Active, Urological
- All makers of Evacuator, Bladder, Manually Operated
Updated July 11, 2016. 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.