# Winter Innovations, Inc. (specification developer, Eden Prairie, MN): 2 new FDA device listings, incl. needle, suturing, disposable

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Winter Innovations, Inc. |
| Owner / operator | Winter Innovations |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Eden Prairie, MN, US |
| New listings | 2 |
| Devices | Needle, Suturing, Disposable; Suture, Nonabsorbable, Synthetic, Polyethylene |
| Product codes | GAB, GAT |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery |
| Brand names | EasyWhip; EasyWhip Family |
| First new listing | 2026-07-15 |
| Latest new listing | 2026-07-15 |
| FDA registration number | 3021190802 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.