Cleared Special

K110913 - ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY

K110913 is an FDA 510(k) clearance for ESTECH COBRA SURGICAL SYSTEM WITH THERM..., manufactured by Endoscopic Technologies, Inc. D/B/A Estech. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Special 510(k) pathway after a 175-day FDA review.

K110913 · Endoscopic Technologies, Inc. D/B/A Estech · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K110913

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Modification to existing cleared device.

OCL Device Classification - Class 2, Special Controls

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.
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767 · Medtronic, Inc. · Jul 2012
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
K121451 · Medtronic, Inc. · Jun 2012
ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
K113475 · Endoscopic Technologies, Inc. D/B/A Estech · Mar 2012
ATRICURE BIPOLAR SYSTEM
K110117 · AtriCure, Inc. · Apr 2011
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
K101174 · AtriCure, Inc. · Nov 2010
MULTIFUNCTIONAL LINEAR PEN
K100501 · AtriCure, Inc. · Jun 2010
K110913 · ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
Download PDF FDA Summary Endoscopic Technologi…