Cleared Traditional

MediClear PreOp

K163556 · Covalontechnologies, Inc. · General Hospital
Sep 2017
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K163556 is an FDA 510(k) clearance for the MediClear PreOp, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Covalontechnologies, Inc. (Mississsauga, CA). The FDA issued a Cleared decision on September 14, 2017, 269 days after receiving the submission on December 19, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K163556 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2016
Decision Date September 14, 2017
Days to Decision 269 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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