Cleared Traditional

PROXIDERM (D-460,D 90 460,D 180,460, PS 460) (K970439) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K970439 · Progressive Surgical Products, Inc. · General & Plastic Surgery device
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Apr 1997
Decision
70d
Days
Class 1
Risk

K970439 is an FDA 510(k) clearance for the PROXIDERM (D-460,D 90 460,D 180,460, PS 460). Classified as System, Skin Closure (product code MKY), Class I - General Controls.

Submitted by Progressive Surgical Products, Inc. (Westbury, US). The FDA issued a Cleared decision on April 16, 1997 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4320 - 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 Progressive Surgical Products, Inc. devices

Submission Details

510(k) Number K970439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1997
Decision Date April 16, 1997
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MKY System, Skin Closure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4320
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.