Cleared Traditional

K942425 - PROXIDERM (TENTATIVE)

K942425 is an FDA 510(k) clearance for PROXIDERM (TENTATIVE), manufactured by Progressive Surgical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MKY cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K942425 · Progressive Surgical Products, Inc. · General & Plastic Surgery device
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Nov 1994
Decision
168d
Days
Class 1
Risk

K942425 is an FDA 510(k) clearance for the PROXIDERM (TENTATIVE). 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 November 4, 1994 after a review of 168 days - an extended review 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: 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 Progressive Surgical Products, Inc. devices

FDA 510(k) Submission Details - K942425

510(k) Number K942425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1994
Decision Date November 04, 1994
Days to Decision 168 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
53d slower than avg
Panel avg: 115d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

MKY Device Classification - Class 1, General Controls

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.