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EasyWhip EW-04S-1

by Winter Innovations, Inc.

EasyWhip EW-04S-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 00860014630712), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K261021

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860014630712 UDI-DI Date1 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK261021 Date1 Jul 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K261021 decided 1 Jul 2026 Active
  • FDA GUDID UDI-DI 00860014630712 listed 1 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K261021
  2. Listed FDA GUDID 00860014630712

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EasyWhip
Generic name
Suturing unit, single-use
Model / Ref / Catalog
EW-04S-1
Primary DI / UDI-DI
00860014630712
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

Related devices

Cleared under the same submission (K261021)

and 1 more cleared under K261021

Similar devices

Other devices filed under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Other devices from Winter Innovations, Inc.

  • EasyWhip EW-03S-1

    Class II

  • EasyWhip EW-03C-1

    Class II

  • EasyWhip EW-02S-1

    Class II

  • EasyWhip EW-02C-1

    Class II

See all devices from Winter Innovations, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)