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510(k) K160366

Electrosurgical disposable grounding pads by Top-Rank Health Care Co., Ltd. — Product Code ODR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2016
Date Received
February 9, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical Patient Return Electrode
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

Other clearances by Top-Rank Health Care Co., Ltd.

  • K232020 — Iontophoresis Electrodes (October 16, 2023)
  • K222770 — Conductive Gel (December 13, 2022)
  • K210223 — Transcutaneous Electrical Nerve Stimulator (December 15, 2021)

Other clearances for product code ODR

  • K121268 — WANDY DISPERSVIE ELECTRODE (December 20, 2012)
  • K082204 — SERIES SY DISPOSABLE ELECTROSURGICAL PAD (August 13, 2008)