Cleared Special

ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY (K110913) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K110913 · Endoscopic Technologies, Inc. D/B/A Estech · Cardiovascular device
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Sep 2011
Decision
175d
Days
Class 2
Risk

K110913 is an FDA 510(k) clearance for the ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY. Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by Endoscopic Technologies, Inc. D/B/A Estech (San Ramon, US). The FDA issued a Cleared decision on September 23, 2011 after a review of 175 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - the FDA cardiovascular device oversight 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.

View all Endoscopic Technologies, Inc. D/B/A Estech devices

Submission Details

510(k) Number K110913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2011
Decision Date September 23, 2011
Days to Decision 175 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac 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 Cardiovascular devices follow this clearance model.

Regulatory Peers - OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

All 53
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K110913.
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AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
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K211311 · AtriCure, Inc. · May 2021