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K Number
K983788
Device Name
AARON COOLPAD SPLIT W/O CORD,AARON COOLPAD SPLIT WITH CORD, AARON COOLPAD W/O CORD, ARRON COOLPAD WITH CORD, MODELS ESRE
Manufacturer
AARON MEDICAL INDUSTRIES
Date Cleared
1998-11-25

(29 days)

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

This device is intended to be used in general electrosurgical procedures as a return electrode in the electrosurgical circuit between the patient and the electrosurgical generator.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The text is an FDA clearance letter for a medical device (Aaron Coolpad) and outlines its regulatory classification and marketing approval. It does not include details about performance criteria, trial designs, sample sizes, expert qualifications, or ground truth establishment.

§ 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.