Cleared Traditional

K925805 - KENDALL WOUND DRAINAGE SYSTEMS-TROCARS (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K925805 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
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Feb 1993
Decision
102d
Days
Class 1
Risk

K925805 is an FDA 510(k) clearance for the KENDALL WOUND DRAINAGE SYSTEMS-TROCARS. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on February 26, 1993 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kendall Healthcare Products Co. Div.Of Tyco Health devices

Submission Details

510(k) Number K925805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date February 26, 1993
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 114d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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.