Cleared Traditional

SUPERSKIN (K972081) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K972081 · Medlogic Global Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
197d
Days
Class 1
Risk

K972081 is an FDA 510(k) clearance for the SUPERSKIN. Classified as Bandage, Liquid, Skin Protectant (product code NEC), Class I - General Controls.

Submitted by Medlogic Global Corp. (Washington, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 197 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 Medlogic Global Corp. devices

Submission Details

510(k) Number K972081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1997
Decision Date December 17, 1997
Days to Decision 197 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
82d slower than avg
Panel avg: 115d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NEC Bandage, Liquid, Skin Protectant
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.