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510(k) K082204

SERIES SY DISPOSABLE ELECTROSURGICAL PAD by Ventlab Corp. — Product Code ODR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2008
Date Received
August 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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.

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Other clearances for product code ODR

  • K160366 — Electrosurgical disposable grounding pads (August 19, 2016)
  • K121268 — WANDY DISPERSVIE ELECTRODE (December 20, 2012)