Cleared Traditional

K082204 - SERIES SY DISPOSABLE ELECTROSURGICAL PAD
(FDA 510(k) Clearance)

K082204 · Ventlab Corp. · General & Plastic Surgery
Aug 2008
Decision
8d
Days
Class 2
Risk

K082204 is an FDA 510(k) clearance for the SERIES SY DISPOSABLE ELECTROSURGICAL PAD. This device is classified as a Electrosurgical Patient Return Electrode (Class II — Special Controls, product code ODR).

Submitted by Ventlab Corp. (Crofton, US). The FDA issued a Cleared decision on August 13, 2008, 8 days after receiving the submission on August 5, 2008.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. 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..

Submission Details

510(k) Number K082204 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2008
Decision Date August 13, 2008
Days to Decision 8 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code ODR — Electrosurgical Patient Return Electrode
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400
Definition 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.