Cleared Traditional

SPAND-GEL GRANULATED GEL (K864124) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K864124 · Medi-Tech Intl. Corp. · General & Plastic Surgery device
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Nov 1986
Decision
36d
Days
Class 1
Risk

K864124 is an FDA 510(k) clearance for the SPAND-GEL GRANULATED GEL. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Medi-Tech Intl. Corp. (Brooklyn, US). The FDA issued a Cleared decision on November 26, 1986 after a review of 36 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 Medi-Tech Intl. Corp. devices

Submission Details

510(k) Number K864124 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 21, 1986
Decision Date November 26, 1986
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
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.

Regulatory Peers - KMF Bandage, Liquid

All 221
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K820134 · C.R. Bard, Inc. · Feb 1982