Cleared Traditional

Gemini Sterilization Wrap

K220365 · Medline Industries, LP · General Hospital
Oct 2022
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K220365 is an FDA 510(k) clearance for the Gemini Sterilization Wrap, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Medline Industries, LP (Nortfield, US). The FDA issued a Cleared decision on October 6, 2022, 240 days after receiving the submission on February 8, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K220365 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2022
Decision Date October 06, 2022
Days to Decision 240 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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