EasyWhip EW-03S-1
EasyWhip EW-03S-1 is a Class II device made by Winter Innovations, Inc., cleared under FDA 510(k) K261021 on 1 Jul 2026 and listed in FDA GUDID since 1 Aug 2026 (UDI-DI 00860007711251), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860007711251 | Date1 Aug 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK261021 | Date1 Jul 2026 | StatusActive |
Official records
- AccessGUDID record 00860007711251
- FDA 510(k) database K261021
Across registries
- FDA 510(k) K261021 decided 1 Jul 2026 Active
- FDA GUDID UDI-DI 00860007711251 listed 1 Aug 2026 Listed
Timeline
- Cleared FDA 510(k) K261021
- Listed FDA GUDID 00860007711251
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EasyWhip
- Generic name
- Suturing unit, single-use
- Model / Ref / Catalog
- EW-03S-1
- Primary DI / UDI-DI
- 00860007711251
- 510(k) Number
- FDA product code
- GAT
- GMDN term
- Suturing unit, single-use
- Device class
- Class II
- Regulation number
- 878.5000
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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