Cleared Traditional

ControlRad Sterile Cover

K200238 · Controlrad, Inc. · General Hospital
Apr 2020
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K200238 is an FDA 510(k) clearance for the ControlRad Sterile Cover, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Controlrad, Inc. (Norcross, US). The FDA issued a Cleared decision on April 26, 2020, 86 days after receiving the submission on January 31, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K200238 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2020
Decision Date April 26, 2020
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KKX — Drape, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370

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