Data / Medical devices / United States / Silk Holdings, Inc.
Silk Holdings, Inc.: FDA-registered device maker in Needham, MA, United States, 1 510(k) clearance
Silk Holdings, Inc. is registered with the FDA (registration 3046433871) in Needham, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3046433871
- Address
- 117 Kendrick St Ste 700, Needham, MA, United States, 02494
- Owner or operator
- Evolved Health, Inc. (10096070)
- Roles
- Manufacturer
- First device listed
- June 17, 2026
- Registered through
- 2026
- Brand names listed
- New Day Skin Spray
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | 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 |
|---|---|---|---|---|---|---|
| January 23, 2026 | K252568 | New Day Skin Spray | FRO | Substantially Equivalent | Silk Holdings, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 23, 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.