Data / Medical devices / United States / Freyja Healthcare, LLC
Freyja Healthcare, LLC: FDA-registered device maker in Boston, MA, United States, 2 510(k) clearances
Freyja Healthcare, LLC is registered with the FDA (registration 3021875817) in Boston, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 20, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021875817
- Address
- 38 Wareham St, Boston, MA, United States, 02118
- Owner or operator
- Freyja Healthcare, LLC (10092037)
- Roles
- Specification developer
- First device listed
- November 27, 2024
- Registered through
- 2026
- Brand names listed
- VereSee, VereSee Optical Veres Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | 2 | Specification developer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 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 |
|---|---|---|---|---|---|---|
| October 20, 2025 | K252640 | VereSee Optical Veres Needle and Endoscopic Camera | GCJ | Substantially Equivalent | Freyja Healthcare, LLC | accessdata.fda.gov |
| May 2, 2024 | K232464 | VereSee Optical Veres Needle System | HIF | Substantially Equivalent | Freyja Healthcare, LLC | accessdata.fda.gov |
Compare with other makers
Updated October 20, 2025. 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.