Cleared Traditional

K030574 - GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K030574 · Glustitch, Inc. · General & Plastic Surgery device
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Aug 2003
Decision
178d
Days
Class 1
Risk

K030574 is an FDA 510(k) clearance for the GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Glustitch, Inc. (Delta, CA). The FDA issued a Cleared decision on August 21, 2003 after a review of 178 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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 Glustitch, Inc. devices

Submission Details

510(k) Number K030574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2003
Decision Date August 21, 2003
Days to Decision 178 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 114d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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.