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Advantage Single-Use Electrosurgical Attachment-J-Hook Tip, L-Hook Tip, Corbitt…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K010444

by C. R. Bard, Inc.

Identifiers

510(k) Number
K010444 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an electrosurgical cutting and coagulation accessory classified under product code GEI. It consists of single-use attachments with various tip configurations including J-hook, L-hook, Corbitt spatula, ball, and needle tips.

The device is supplied sterile and intended for single-use only. It received FDA 510(k) clearance (K010444) on February 28, 2001, as substantially equivalent to a predicate device, and is regulated as a Class II medical device requiring special controls.

Frequently asked questions

What is the ADVANTAGE single-use electrosurgical attachment used for?

The ADVANTAGE single-use electrosurgical attachment is used for cutting and coagulation during electrosurgical procedures, with tip configurations including J-hook, L-hook, Corbitt spatula, ball, and needle tips to suit various surgical needs.

How is the ADVANTAGE electrosurgical attachment supplied and is it reusable?

The device is supplied sterile and intended for single-use only, meaning it must be discarded after one procedure to prevent cross-contamination and ensure optimal performance.

What regulatory pathway was used for the ADVANTAGE electrosurgical attachment?

The ADVANTAGE electrosurgical attachment received FDA 510(k) clearance (K010444) on February 28, 2001, as substantially equivalent to a predicate device, and is regulated as a Class II medical device requiring special controls.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Advantage Single-use Electrosurgical Attachment-j-hook Tip, L-hook Tip ..., K010444 FDA 510 (k) - ADVANTAGE SINGLE-USE ELECTROSURGICAL AT..., Advantage Single-use Electrosurgical Attachment-j-hook Tip, L-hook Tip ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K010444 24 fields · synced Oct 1, 2026