Cleared Special

K141095 - STRYKER STERI-SHIELD FLYTE HYBRID TOGAS

K141095 is the FDA 510(k) clearance for STRYKER STERI-SHIELD FLYTE HYBRID TOGAS by Stryker Corporation. It is a Class 2 General Hospital device (product code FYA) cleared through the Special 510(k) pathway after a 120-day FDA review.

K141095 · Stryker Corporation · General Hospital
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Aug 2014
Decision
120d
Days
Class 2
Risk

K141095 is an FDA 510(k) clearance for the STRYKER STERI-SHIELD FLYTE HYBRID TOGAS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on August 26, 2014 after a review of 120 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Corporation devices

Submission Details

510(k) Number K141095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2014
Decision Date August 26, 2014
Days to Decision 120 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 129d · This submission: 120d
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 128
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