EasyWhip EW-01-1
EasyWhip EW-01-1 is a Class II device made by Winter Innovations, Inc., cleared under FDA 510(k) K210675 on 3 May 2021 and listed in FDA GUDID since 18 Nov 2021 (UDI-DI 00860007711206), 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 | Number00860007711206 | Date18 Nov 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210675 | Date3 May 2021 | StatusActive |
Official records
- AccessGUDID record 00860007711206
- FDA 510(k) database K210675
Across registries
- FDA 510(k) K210675 decided 3 May 2021 Active
- FDA GUDID UDI-DI 00860007711206 listed 18 Nov 2021 Listed
Timeline
- Cleared FDA 510(k) K210675
- Listed FDA GUDID 00860007711206
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- Withdrawn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-01-1
- Primary DI / UDI-DI
- 00860007711206
- 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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