Cleared Special

K993148 - STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA

K993148 is an FDA 510(k) clearance for STRYKER T4 HOOD, manufactured by Stryker Instruments. 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.

K993148 · Stryker Instruments · General Hospital
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Oct 1999
Decision
24d
Days
Class 2
Risk

K993148 is an FDA 510(k) clearance for the STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on October 15, 1999 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 - K993148

510(k) Number K993148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1999
Decision Date October 15, 1999
Days to Decision 24 days
Submission Type Special
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
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 296
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K993148.
CONVERTORS SURGICAL GOWNS, STERILE
K994244 · Allegiance Healthcare Corp. · Feb 2000
GOWN BACK, MODEL 13-403N
K992436 · Techstyles · Jan 2000
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE
K994053 · Stryker Instruments · Dec 1999
CONVERTORS SURGICAL GOWNS
K992951 · Allegiance Healthcare Corp. · Sep 1999
CONVERTORS BREATHABLE SURGICAL GOWNS
K992514 · Allegiance Healthcare Corp. · Aug 1999
CONVERTORS SURGICAL GOWNS
K991034 · Allegiance Healthcare Corp. · Apr 1999
K993148 · STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA
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