Cleared Traditional

K063245 - ELUTIA COATED CLOSED SURGICAL WOUND DRAIN (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K063245 · Bacterin International, Inc. · General & Plastic Surgery device
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Nov 2007
Decision
398d
Days
Class 2
Risk

K063245 is an FDA 510(k) clearance for the ELUTIA COATED CLOSED SURGICAL WOUND DRAIN. Classified as Drainage Catheter With Antibiotic (product code OEI), Class II - Special Controls.

Submitted by Bacterin International, Inc. (Shelton, US). The FDA issued a Cleared decision on November 28, 2007 after a review of 398 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - 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. Elevated predicate reliance profile. 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 Bacterin International, Inc. devices

Submission Details

510(k) Number K063245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2006
Decision Date November 28, 2007
Days to Decision 398 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
284d slower than avg
Panel avg: 114d · This submission: 398d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OEI Drainage Catheter With Antibiotic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
Definition A Tubular Drain Made From Silicone Or Similar Material And Is Coated With A Silver Containing Material And Is Intended To Drain Fluids From Body Cavities Using Gravity Drainage Or Attached To A Suction Pump.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.