Cleared Traditional

EasyWhip (K210675) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210675 · Winter Innovations, Inc. · General & Plastic Surgery device
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May 2021
Decision
59d
Days
Class 2
Risk

K210675 is an FDA 510(k) clearance for the EasyWhip. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Winter Innovations, Inc. (Knoxville, US). The FDA issued a Cleared decision on May 3, 2021 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Winter Innovations, Inc. devices

Submission Details

510(k) Number K210675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2021
Decision Date May 03, 2021
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 73
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K210675.
Zone Specific AIM
K220186 · Conmed Corporation · May 2022
PERMALOOP Suture, PERMATAPE Suture
K220219 · Medos International SARL · Apr 2022
Arthrex LoopLoc Knotless Suture
K212146 · Arthrex, Inc. · Oct 2021
DYNATAPE Suture
K203186 · Medos International SARL · Mar 2021
FAST-FIX FLEX
K203393 · Smith & Nephew, Inc. · Feb 2021
Arthrex SoftStitch
K190707 · Arthrex, Inc. · Oct 2020