Cleared Traditional

DECA DERMATOME (MICROMOTOR SYSTEM) (K945594) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K945594 · Depuy Intl., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
203d
Days
Class 1
Risk

K945594 is an FDA 510(k) clearance for the DECA DERMATOME (MICROMOTOR SYSTEM). Classified as Dermatome (product code GFD), Class I - General Controls.

Submitted by Depuy Intl., Ltd. (West Yorkshire, GB). The FDA issued a Cleared decision on June 5, 1995 after a review of 203 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 Depuy Intl., Ltd. devices

Submission Details

510(k) Number K945594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1994
Decision Date June 05, 1995
Days to Decision 203 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
88d slower than avg
Panel avg: 115d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GFD Dermatome
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.