Cleared Traditional

K073663 - GELSPRAY WOUND DRESSING

K073663 is an FDA 510(k) clearance for GELSPRAY WOUND DRESSING, manufactured by Biocure, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K073663 · Biocure, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
35d
Days
Class 1
Risk

K073663 is an FDA 510(k) clearance for the GELSPRAY WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Biocure, Inc. (South West Ranches, US). The FDA issued a Cleared decision on January 30, 2008 after a review of 35 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.

FDA 510(k) Submission Details - K073663

510(k) Number K073663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date January 30, 2008
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
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 217
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K073663.
GLUSEAL 90, MODEL GLU9010
K083752 · Glustitch, Inc. · Feb 2009
MRDH BANDAGE
K082703 · Marine Polymer Technologies, Inc. · Oct 2008
NEUTROPHASE
K081009 · Novabay Pharmaceuticals · May 2008
PRODERMA LIQUID BANDAGE
K063202 · Procurement Technology Systems, LLC · May 2007
SILVERLON DIRECT PRESSURE WOUND DRESSING
K984207 · Argentum International, LLC · Mar 2007
BAND-AID(R) BRAND LIQUID BANDAGE
K062602 · Johnson & Johnson Consumer Companies, Inc. · Dec 2006
K073663 · GELSPRAY WOUND DRESSING
Download PDF FDA Summary Biocure, Inc.