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Accu-Surg Bi-Polar Electrodes, L-Hook, Needle, Ball, Bipolar Cord

by Transamerican Technologies Intl.

510(k) K971677

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 NumberK971677 Date20 Aug 1997ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Accu-Surg Bi-Polar Electrodes are laparoscopic surgical instruments designed for cutting and coagulation during general and gynecological procedures. These bipolar electrodes include L-hook, needle, and ball configurations and are used in conjunction with the Accu-Surg Suction/Irrigation Cannula. They function as electrosurgical tools for tissue dissection and hemostasis in minimally invasive surgery.

The device is supplied as a single-use, sterile instrument and is intended for one-time surgical application. It is classified under the FDA product code GEI and was cleared through the 510(k) premarket notification process under number K971677. Storage conditions and MRI safety specifications are not detailed in the available regulatory data.

Other devices from Transamerican Technologies Intl.

Questions

AI-generated answers, 25 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 procedures are these bipolar electrodes used for?

    These electrodes are designed for laparoscopic cutting and coagulation during general and gynecological procedures. They support tissue dissection and hemostasis in minimally invasive surgery when used with the Accu-Surg Suction/Irrigation Cannula.

  • How is the device supplied and is it sterile?

    The device is supplied as a single-use, sterile instrument intended for one-time surgical application. It is not designed for reuse and should be discarded after a single procedure to maintain sterility and safety.

  • What configurations are available?

    The device is available in L-hook, needle, and ball electrode configurations. These variants allow surgeons to select the appropriate tip shape for different tissue types and surgical techniques during laparoscopic procedures.

  • What is the regulatory clearance status?

    The device was cleared through the FDA 510(k) premarket notification process under number K971677. It is classified under FDA product code GEI and was determined to be substantially equivalent to existing devices.

  • Are there any special storage requirements?

    Storage conditions and MRI safety specifications are not detailed in the available regulatory data. Users should refer to the manufacturer's labeling or contact Transamerican Technologies Intl. for specific storage instructions prior to use.