ELECTROSURGICAL PROBE

K963901 · Smith & Nephew Endoscopy, Inc. · GEI · Nov 4, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963901
• Device Name: ELECTROSURGICAL PROBE
• Applicant: Smith & Nephew Endoscopy, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Excise tissue and coagulate tissue.

Device Story

Endoscopic electrosurgical probe and handle; used with electrical generator; functions to excise tissue and coagulate bleeding. Operated by surgeons in endoscopic clinical settings. Device provides mechanical interface for electrosurgical energy delivery to target tissue. Output is thermal effect on tissue for cutting or hemostasis. Benefits include precise tissue management during minimally invasive procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical design and function to predicate device.

Technological Characteristics

Electrosurgical probe and handle; energy source provided by external electrical generator. Design and materials identical to predicate device.

Indications for Use

Indicated for patients requiring tissue excision and coagulation during endoscopic surgical procedures.

Regulatory Classification

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.

Predicate Devices

• K901505

Submission Summary (Full Text)

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K96 3901
Smith & Nephew Endoscopy, Inc.
160 Dascomb Road
Andover, MA 01810 U.S.A.
Telephone [phone]
Fax [phone]
Smith & Nephew
NOV - 4 1996

# 510(k) Summary
Smith & Nephew Endoscopy Endoscopic Electrosurgical Probe and Handle

## Substantial Equivalence :

The Smith & Nephew Endoscopy Disposable Endoscopic Electrosurgical Probe and Handle were originally determined to be substantially equivalent to pre-amendment devices under 510(k) K901505..

## Predicate Device :

The change discussed in this 510(k) does not affect the method of use, or intended use, of the device. The additional labeling of a voltage limit is a European requirement for CE marking. Other changes to this device are user convenience features only.

## Summary of Device Function :

Smith & Nephew Endoscopy Endoscopic Electrosurgical Probe and Handle is used in conjunction with an electrical generator to excise tissue and coagulate bleeding.

## Intended Use of Device :

Excise tissue and coagulate tissue.

## Comparison of Technological Characteristics of Predicate Device :

The design technologies and function of the items referred to in this 510(k) notification are identical to those listed in the previous Electrosurgery Probe 510(k) submitted by Smith & Nephew Endoscopy, Inc.

Elizabeth A. Ryan
Regulatory Affairs

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