Data / Medical devices / India / Adroit Manufacturing Co.
Adroit Manufacturing Co.: FDA-registered device maker in Umbergaon Gujarat, India, 1 510(k) clearance
Adroit Manufacturing Co. is registered with the FDA (registration 3009401905) in Umbergaon Gujarat, India. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 13, 2000. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009401905
- Address
- Plot No: 138 (EXPN, AREA), GIDC Dist. Valsad, Umbergaon Gujarat, India, 396171
- Owner or operator
- ADROIT MANUFACTURING CO. (10040349)
- Roles
- Manufacturer
- First device listed
- April 3, 2012
- Registered through
- 2026
- Brand names listed
- SET, ANESTHESIA,PARACERVICAL, Trocar, Tunneler
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer | accessdata.fda.gov |
| Set, Anesthesia, Paracervical | HEE | 2 | 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 |
|---|---|---|---|---|---|---|
| April 13, 2000 | K000117 | AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE | HEE | Substantially Equivalent | Avid Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 13, 2000. 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.