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Cobra Surgical Probe

by Boston Scientific

510(k) K040219

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK040219 Date24 Feb 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
GEI
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cobra Surgical Probe is a device intended for the coagulation of cardiac tissue. It is manufactured by Boston Scientific Corporation and is classified under product code GEI.

The device is supplied as a single-use instrument and is not indicated for MRI use. It received FDA 510(k) clearance with number K040219 on February 24, 2004, as substantially equivalent under special review by the General and Plastic Surgery advisory committee.

Other devices from Boston Scientific

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the COBRA Surgical Probe used for?

    The COBRA Surgical Probe is a device intended specifically for the coagulation of cardiac tissue. It is designed to provide controlled tissue ablation during cardiac procedures, helping to create lesions or stop bleeding in cardiac tissue.

  • Is the COBRA Surgical Probe reusable or single-use?

    The COBRA Surgical Probe is supplied as a single-use instrument only. It is not designed or approved for reuse, and should be discarded after a single procedure to ensure patient safety and device performance.

  • What regulatory approvals does the COBRA Surgical Probe have?

    The COBRA Surgical Probe received FDA 510(k) clearance with number K040219 on February 24, 2004. It was determined to be substantially equivalent under special review by the General and Plastic Surgery advisory committee.

  • Can the COBRA Surgical Probe be used in MRI procedures?

    No, the COBRA Surgical Probe is not indicated for MRI use. The device should not be used in MRI environments as it has not been tested or approved for such conditions, which could pose safety risks or affect device performance.