ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP

• K Number: K010444
• Device Name: ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP
• Manufacturer: C.R. BARD, INC.
• Date Cleared: 2001-02-28 ( 14 days)
• Product Code: GEI
• Regulation Number: 878.4400

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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