Cleared Traditional

Sterilization Wrap

K222151 · Kenpax International Limited · General Hospital
Mar 2023
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K222151 is an FDA 510(k) clearance for the Sterilization Wrap, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Kenpax International Limited (Hong Kong, CN). The FDA issued a Cleared decision on March 23, 2023, 246 days after receiving the submission on July 20, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K222151 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2022
Decision Date March 23, 2023
Days to Decision 246 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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