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FDA 510(k)

ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM

K-Number: K113475 · 2012-03-20

ApplicantEndoscopic Technologies, Inc. D/B/A Estech
Decision Date2012-03-20
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endoscopic Technologies, Inc. D/B/A Estech. It received FDA 510(k) clearance on 2012-03-20 under 510(k) number K113475. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM?

ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-20. The listed applicant is Endoscopic Technologies, Inc. D/B/A Estech. The 510(k) number is K113475.

When did ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM receive FDA 510(k) clearance?

ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM received FDA 510(k) clearance on 2012-03-20, under 510(k) number K113475.

Who is the listed applicant for ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM?

The FDA 510(k) record lists Endoscopic Technologies, Inc. D/B/A Estech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM?

The FDA product code for ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM is OCL.

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Other records listing Endoscopic Technologies, Inc. D/B/A Estech as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110913ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORYK100224ESTECH COBRA BIPOLSR IIK091542ESTECH EASYFLOW CANNULA WITH GUIDEWIREK091350ESTECH HAWKEYE INTRODUCER SYSTEMS

Related Devices (Code: OCL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)AtriCure, Inc.K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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