EasyWhip Family

FDA 510(k) K261021 · Winter Innovations, Inc.

Substantially Equivalent

510(k) numberK261021

Submission

Device name
EasyWhip Family
Applicant
Winter Innovations, Inc.
Knoxville, TN, US
Received
March 27, 2026
Decision date
July 1, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5000
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was EasyWhip Family cleared by the FDA?

EasyWhip Family (K261021) received a 510(k) decision of Substantially Equivalent on July 1, 2026, 96 days after the submission was received.

What is the product code of K261021?

The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.