Cleared Special

STRYKER STRI-SHIELD FLYTE TOGAS (K073017) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K073017 · Stryker Instruments, Instruments Div. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
36d
Days
Class 2
Risk

K073017 is an FDA 510(k) clearance for the STRYKER STRI-SHIELD FLYTE TOGAS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Stryker Instruments, Instruments Div. (Kalamazoo, US). The FDA issued a Cleared decision on November 30, 2007 after a review of 36 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Instruments, Instruments Div. devices

Submission Details

510(k) Number K073017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2007
Decision Date November 30, 2007
Days to Decision 36 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FYA Gown, 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 - FYA Gown, Surgical

All 104
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K073017.
Blockade Surgical Gown
K150598 · Medline Industries, Inc. · Apr 2016
TOTAL SHIELD SURGICAL
K142166 · Zimmer, Inc. · Aug 2014
TOTALSHIELD SURGICAL HELMET SYSTEM
K132386 · Zimmer, Inc. · Dec 2013
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
K062969 · Medline Industries, Inc. · Dec 2006
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
K043017 · Medline Industries, Inc. · Mar 2005
MEDLINE SURGICAL GOWNS
K043585 · Medline Industries, Inc. · Mar 2005