Cleared Traditional

Medline Reusable Sterilization Wrappers

K234132 · Medline Industries, LP · General Hospital
Sep 2024
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K234132 is an FDA 510(k) clearance for the Medline Reusable Sterilization Wrappers, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Medline Industries, LP (Northfield, US). The FDA issued a Cleared decision on September 17, 2024, 264 days after receiving the submission on December 28, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K234132 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2023
Decision Date September 17, 2024
Days to Decision 264 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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