Cleared Traditional

GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE (K913696) - FDA 510(k) Clearance

K913696 · Vertex Technical Group, Inc. · General & Plastic Surgery device
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Feb 1992
Decision
183d
Days
-
Risk

K913696 is an FDA 510(k) clearance for the GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE.

Submitted by Vertex Technical Group, Inc. (Bethesda, US). The FDA issued a Cleared decision on February 18, 1992 after a review of 183 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Vertex Technical Group, Inc. devices

Submission Details

510(k) Number K913696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date February 18, 1992
Days to Decision 183 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
68d slower than avg
Panel avg: 115d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -