Cleared Special

FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS

K140588 · Stryker Corporation · General Hospital
Jun 2014
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K140588 is an FDA 510(k) clearance for the FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS, a Hood, Surgical (Class II — Special Controls, product code FXY), submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on June 26, 2014, 111 days after receiving the submission on March 7, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K140588 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2014
Decision Date June 26, 2014
Days to Decision 111 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FXY — Hood, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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