Cleared Traditional

K083752 - GLUSEAL 90

K083752 is an FDA 510(k) clearance for GLUSEAL 90, manufactured by Glustitch, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K083752 · Glustitch, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
68d
Days
Class 1
Risk

K083752 is an FDA 510(k) clearance for the GLUSEAL 90, MODEL GLU9010. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Glustitch, Inc. (Delta, CA). The FDA issued a Cleared decision on February 23, 2009 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Glustitch, Inc. devices

FDA 510(k) Submission Details - K083752

510(k) Number K083752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2008
Decision Date February 23, 2009
Days to Decision 68 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
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

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.

Regulatory Peers - KMF Bandage, Liquid

All 92
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K083752.
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