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Estech Cobra Adhere Xl 2 Surgical System

by Endoscopic Technologies, Inc. D/B/A Estech

510(k) K113475

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113475 Date20 Mar 2012ClearedStatusActive

Recalls

5 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0832-2019 FDA Class II initiated 22 Jan 2019
    • Terminated Z-0830-2019 FDA Class II initiated 22 Jan 2019
    • Terminated Z-0829-2019 FDA Class II initiated 22 Jan 2019
    • Terminated Z-0831-2019 FDA Class II initiated 22 Jan 2019

    There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

    • Terminated Z-0653-2017 FDA Class II initiated 22 Sep 2016

    Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OCL
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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