Cleared Traditional

K060054 - ONCOBIONIC SYSTEM

K060054 is an FDA 510(k) clearance for ONCOBIONIC SYSTEM, manufactured by Oncobionics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OAB cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K060054 · Oncobionics, Inc. · General & Plastic Surgery device
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Nov 2006
Decision
319d
Days
Class 2
Risk

K060054 is an FDA 510(k) clearance for the ONCOBIONIC SYSTEM. Classified as Low Energy Direct Current Thermal Ablation System (product code OAB), Class II - Special Controls.

Submitted by Oncobionics, Inc. (Washington, US). The FDA issued a Cleared decision on November 21, 2006 after a review of 319 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 878.4400 - 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 Oncobionics, Inc. devices

FDA 510(k) Submission Details - K060054

510(k) Number K060054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2006
Decision Date November 21, 2006
Days to Decision 319 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
204d slower than avg
Panel avg: 115d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAB Device Classification - Class 2, Special Controls

Product Code OAB Low Energy Direct Current Thermal Ablation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Ablation Of Soft Tissue
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.