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EasyWhip Family

Winter Innovations, Inc. · K261021

FDA-authorized Predetermined Change Control Plan

1 of 79 Non-AI1 of 9 in General, Plastic Surgeryauthorized 2026
Company
Winter Innovations, Inc.
510(k)/De Novo #
K261021
Decision date
2026-07-01
Panel
General, Plastic Surgery
Pathway
510(k)
Category
Non-AI
PCCP type
Hardware
Monitoring commitment
Not stated

What this PCCP covers. Permits hardware configuration changes

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Other General, Plastic Surgery PCCPs

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We read the PCCP for EasyWhip Family, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.

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Source: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.

This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.