Cleared Special

K070078 - STRYKER T4 HYTREL TOGA

K070078 is an FDA 510(k) clearance for STRYKER T4 HYTREL TOGA, manufactured by Stryker Instruments, Instruments Div.. The device is a Class 2 General Hospital device with product code FYA cleared through the Special 510(k) pathway after a 24-day FDA review.

K070078 · Stryker Instruments, Instruments Div. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
24d
Days
Class 2
Risk

K070078 is an FDA 510(k) clearance for the STRYKER T4 HYTREL TOGA. 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 February 2, 2007 after a review of 24 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.

FDA 510(k) Submission Details - K070078

510(k) Number K070078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2007
Decision Date February 02, 2007
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
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 259
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K070078.
WELMED, INC. SURGICAL GOWNS
K070431 · Welmed, Inc. · May 2007
STRYKER T6 HOODS AND TOGAS
K063005 · Stryker Instruments · Mar 2007
JOYKEY SURGICAL GOWNS (STERILE)
K062479 · Joykey Industryial , Ltd. · Mar 2007
MICROTEK MEDICAL SURGICAL GOWN/TOGA
K062899 · Microtek Medical, Inc. · Jan 2007
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
K062969 · Medline Industries, Inc. · Dec 2006
LAC-MAC INNERBLOC O.R. GOWN
K061491 · Lac Mac, Ltd. · Aug 2006