Cleared Traditional

K012738 - SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K012738 · Depuyacromed · General & Plastic Surgery device
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Nov 2001
Decision
90d
Days
Class 1
Risk

K012738 is an FDA 510(k) clearance for the SYMPHONY GRAFT DELIVERY SYSTEM (GDS). Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on November 14, 2001 after a review of 90 days - within the typical 510(k) review window.

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 Depuyacromed devices

Submission Details

510(k) Number K012738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2001
Decision Date November 14, 2001
Days to Decision 90 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
24d faster than avg
Panel avg: 114d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEY Motor, Surgical Instrument, Ac-powered
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.