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Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm - Laparoscopic Wire J

by New Deantronics Taiwan, Ltd.

510(k) K183594

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 · Traditional NumberK183594 Date19 Feb 2019ClearedStatusActive

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  • Withdrawn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
Models / Variants
Laparoscopic Wire J
FDA applicant
New Deantronics Taiwan , Ltd.
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.

These devices are laparoscopic bipolar electrodes designed for precise tissue manipulation and coagulation during minimally invasive abdominal or pelvic surgeries. The retractable and hollow designs enable controlled aspiration and electrocautery, reducing tissue trauma while improving visibility and access in confined laparoscopic spaces.

Supplied sterile and intended for single-use, these electrodes are classified under product code GEI and are intended for use in laparoscopic procedures. Each variant features distinct hook or spatula shapes and lengths (28cm or 36cm) to accommodate specific surgical requirements. The devices hold an FDA 510(k) clearance under the General, Plastic Surgery advisory committee, with a decision date of February 19, 2019.

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