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K Number
K061259
Device Name
MODIFICATION TO ARTHROCARE PERC-D SPINEWAND
Manufacturer
ARTHROCARE CORP.
Date Cleared
2006-05-18

(13 days)

Product Code
GEI
Regulation Number
878.4400
Type
Special
Panel
SU
Reference & Predicate Devices
K053447
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

Device Description

The Wands are bipolar, single use, high frequency electrosurgical devices.

AI/ML Overview

I am sorry, but the provided text does not contain any information regarding acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary and an FDA clearance letter for the ArthroCare® Perc-D™ SpineWand™. It discusses the device's labeling and substantial equivalence to a predicate device, but not performance studies with specific metrics.

Therefore, I cannot provide the requested information in the format specified because the necessary data is not present in the input.

§ 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.