510(k) K261021

EasyWhip Family by Winter Innovations, Inc. — Product Code GAT

K261021 is an FDA 510(k) premarket notification submitted by Winter Innovations, Inc. for the device "EasyWhip Family". The FDA issued a decision of Substantially Equivalent on July 1, 2026. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Winter Innovations, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2026
Date Received
March 27, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type