Cleared Traditional

K200493 - 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 is an FDA 510(k) clearance for Stryker T7 Surgical Hoods, manufactured by Stryker Corporation. The device is a Class 2 General Hospital device with product code FXY cleared through the Traditional 510(k) pathway after a 22-day FDA review.

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

K200493 is an FDA 510(k) clearance for the Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Su.... Classified as Hood, Surgical (product code FXY), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on March 21, 2020 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Corporation devices

FDA 510(k) Submission Details - K200493

510(k) Number K200493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXY Device Classification - Class 2, Special Controls

Product Code FXY Hood, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXY Hood, Surgical

All 7
Devices cleared under the same product code (FXY) and FDA review panel - the closest regulatory comparables to K200493.
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
K222214 · Thi Total Healthcare Innovation GmbH · Oct 2023
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
K140588 · Stryker Corporation · Jun 2014
DISPOSABLE BEARD COVER
K904276 · Anago, Inc. · Nov 1990
HOOD, CLARION SURGEONS
K770261 · Sherwood Medical Industries · Mar 1977
HOOD & BEARD COVER, CLARION SURGEON'S
K770257 · Sherwood Medical Industries · Feb 1977
BARRIER SURGICAL HOOD
K760855 · Surgikos, Inc. · Nov 1976