Cleared Special

K141095 - STRYKER STERI-SHIELD FLYTE HYBRID TOGAS

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

K141095 · Stryker Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K141095

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.

FYA Device Classification - Class 2, Special Controls

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 266
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K141095.
SURGICAL GOWN
K141467 · Xuchang Zhengde Environstar Medical Products Co.,L · Mar 2015
SURGICAL GOWN
K141606 · Cobes Industries Co., Ltd. · Nov 2014
TOTAL SHIELD SURGICAL
K142166 · Zimmer, Inc. · Aug 2014
AERO BLUE PERFORMANCE SURGICAL GOWN
K140539 · Kimberly Clark Corporation · Jun 2014
T4/T5 HYTREL TOGAS
K121664 · Stryker Corporation · Mar 2014
TOTALSHIELD SURGICAL HELMET SYSTEM
K132386 · Zimmer, Inc. · Dec 2013
K141095 · STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
Download PDF FDA Summary Stryker Corporation