Cleared Traditional

Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover

K200493 · Stryker Corporation · General Hospital
Mar 2020
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K200493 is an FDA 510(k) clearance for the Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover, a Hood, Surgical (Class II — Special Controls, product code FXY), submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on March 21, 2020, 22 days after receiving the submission on February 28, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K200493 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2020
Decision Date March 21, 2020
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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