Cleared Special

K080202 - ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT

K080202 is an FDA 510(k) clearance for ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT, manufactured by Oncobionics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OAB cleared through the Special 510(k) pathway after a 101-day FDA review.

K080202 · Oncobionics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
101d
Days
Class 2
Risk

K080202 is an FDA 510(k) clearance for the ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT. Classified as Low Energy Direct Current Thermal Ablation System (product code OAB), Class II - Special Controls.

Submitted by Oncobionics, Inc. (Rancho Santa Margarita, US). The FDA issued a Cleared decision on May 8, 2008 after a review of 101 days - within the typical 510(k) review window.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K080202

510(k) Number K080202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2008
Decision Date May 08, 2008
Days to Decision 101 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

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.

K080202 · ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
Download PDF FDA Summary Oncobionics, Inc.