Cleared Traditional

K922441 - SURESEAL BANDAGE (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K922441 · Gainor Medical Europe, Ltd. · General & Plastic Surgery device
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Aug 1993
Decision
445d
Days
Class 1
Risk

K922441 is an FDA 510(k) clearance for the SURESEAL BANDAGE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Gainor Medical Europe, Ltd. (Long Beach, US). The FDA issued a Cleared decision on August 10, 1993 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Gainor Medical Europe, Ltd. devices

Submission Details

510(k) Number K922441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1992
Decision Date August 10, 1993
Days to Decision 445 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
331d slower than avg
Panel avg: 114d · This submission: 445d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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.