Data / Medical devices / United States / Amvaya Holdings, Inc
Amvaya Holdings, Inc: FDA-registered device maker in Branford, CT, United States, 1 510(k) clearance
Amvaya Holdings, Inc is registered with the FDA (registration 3039243252) in Branford, CT, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039243252
- Address
- 265 Thimble Island Rd, Branford, CT, United States, 06405
- Owner or operator
- Amvaya Holdings, Inc (10093851)
- Roles
- Complaint file establishment
- First device listed
- August 1, 2025
- Registered through
- 2026
- Brand names listed
- Plenity
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss | QFQ | 2 | Complaint file establishment | 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 19, 2024 | K230133 | Plenity | QFQ | Substantially Equivalent | Gelesis, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 19, 2024. 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.