Cleared Traditional

ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS (K123212) - FDA 510(k) Clearance

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

K123212 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
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Mar 2013
Decision
144d
Days
Class 2
Risk

K123212 is an FDA 510(k) clearance for the ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS. Classified as Electrosurgical Vessel And/or Tissue Sealer. With Built-in Generator. (product code PDG), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on March 8, 2013 after a review of 144 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. 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 Ethicon Endo-Surgery, LLC devices

Submission Details

510(k) Number K123212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2012
Decision Date March 08, 2013
Days to Decision 144 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
29d slower than avg
Panel avg: 115d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDG Electrosurgical Vessel And/or Tissue Sealer. With Built-in Generator.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Intended For Any Procedure Where Vessel Ligation (cutting And Sealing), Soft Tissue Grasping And Dissection Are Performed.
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.