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CardioVations Optical Bipolar Device (K031846)

by Ethicon Inc.

510(k) K031846

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 NumberK031846 Date21 Jul 2003ClearedStatusActive

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  • Withdrawn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)

Full name
Cardiovations Optical Bipolar Device
510(k) Number
FDA product code
GEI
FDA applicant
ETHICON, Inc.
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 CardioVations Optical Bipolar Device is a bipolar electrosurgical instrument designed for endoscopic and open surgical procedures. It combines dissection, coagulation, and vessel transection capabilities using a knife blade and electrode surface, enabling precise tissue manipulation during surgery.

Supplied sterile and intended for single-patient use, the device features inline jaws for clamping tissue and includes a cannula port for endoscope insertion. It is regulated under FDA 510(k) clearance (K031846) and is classified under product code GEI for general plastic surgery applications. The device incorporates a CO₂ luer connection for additional functionality.

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