Cleared Traditional

K121268 - WANDY DISPERSVIE ELECTRODE (FDA 510(k) Clearance)

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

K121268 · Bio-Med USA, Inc. · General & Plastic Surgery device
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Dec 2012
Decision
238d
Days
Class 2
Risk

K121268 is an FDA 510(k) clearance for the WANDY DISPERSVIE ELECTRODE. Classified as Electrosurgical Patient Return Electrode (product code ODR), Class II - Special Controls.

Submitted by Bio-Med USA, Inc. (Paterson, US). The FDA issued a Cleared decision on December 20, 2012 after a review of 238 days - an extended review cycle.

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. 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 Bio-Med USA, Inc. devices

Submission Details

510(k) Number K121268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2012
Decision Date December 20, 2012
Days to Decision 238 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
124d slower than avg
Panel avg: 114d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODR Electrosurgical Patient Return Electrode
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Ground Pad Used To Finish Circuit During Electrosurgery. A Single Use, Non-sterile Dispersive Electrode With A Pre-attached Cord Used To Adhere To The Patient Over The Entire Pad Surface To Complete The Electrosurgical Circuit Between The Generator, The Active Electrode, And The Patient.
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.