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K Number
K082204
Device Name
SERIES SY DISPOSABLE ELECTROSURGICAL PAD
Manufacturer
VENTLAB CORP.
Date Cleared
2008-08-13

(8 days)

Product Code
ODR
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Ventlab Disposable Electrosurgical Pad is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Ventlab Corporation regarding their Disposable Electrosurgical Pad. This document is a regulatory approval letter and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as would be found in a study report summarized for such a request.

Therefore, I cannot fulfill your request for the specific details outlined in the prompt from this document. The document primarily focuses on:

  • The FDA's determination of substantial equivalence for the device.
  • Regulatory requirements and general controls provisions.
  • Instructions for marketing the device.
  • Contact information for various FDA offices.
  • The intended use of the device.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.