Cleared Traditional

K113475 - ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM

K113475 is an FDA 510(k) clearance for ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM, manufactured by Endoscopic Technologies, Inc. D/B/A Estech. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K113475 · Endoscopic Technologies, Inc. D/B/A Estech · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
119d
Days
Class 2
Risk

K113475 is an FDA 510(k) clearance for the ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM. 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 March 20, 2012 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K113475

510(k) Number K113475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2011
Decision Date March 20, 2012
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 38
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K113475.
COOLRAIL LINEAR PEN MODEL MCRI
K122611 · AtriCure, Inc. · Sep 2012
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767 · Medtronic, Inc. · Jul 2012
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
K121451 · Medtronic, Inc. · Jun 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