Cleared Traditional

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

K233777 · Primed Medical Products, Inc. · General Hospital
May 2024
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K233777 is an FDA 510(k) clearance for the PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600), a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on May 24, 2024, 182 days after receiving the submission on November 24, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K233777 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2023
Decision Date May 24, 2024
Days to Decision 182 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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