Data / Medical devices / United States / Winter Innovations, Inc.
Winter Innovations, Inc.: FDA-registered device maker in Eden Prairie, MN, United States, 2 510(k) clearances
Winter Innovations, Inc. is registered with the FDA (registration 3021190802) in Eden Prairie, MN, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 1, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021190802
- Address
- 7625 Golden Triangle Drive Suite G, Eden Prairie, MN, United States, 55344
- Owner or operator
- Winter Innovations (10083367)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 15, 2021
- Registered through
- 2026
- Brand names listed
- EasyWhip, EasyWhip Family, StitchStand
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Suturing, Disposable | GAB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Complaint file establishment, 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 1, 2026 | K261021 | EasyWhip Family | GAT | Substantially Equivalent | Winter Innovations, Inc. | accessdata.fda.gov |
| May 3, 2021 | K210675 | EasyWhip | GAT | Substantially Equivalent | Winter Innovations, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Suturing, Disposable
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Orthopedic Manual Surgical Instrument
Updated July 1, 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.