Cleared Special

K011755 - STRYKER T4 HYTREL (R) TOGAS (FDA 510(k) Clearance)

Class I General Hospital device.

K011755 · Stryker Corp. · General Hospital
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Jun 2001
Decision
16d
Days
Class 1
Risk

K011755 is an FDA 510(k) clearance for the STRYKER T4 HYTREL (R) TOGAS. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on June 22, 2001 after a review of 16 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 Corp. devices

Submission Details

510(k) Number K011755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2001
Decision Date June 22, 2001
Days to Decision 16 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 128d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LYU Accessory, Surgical Apparel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.