Who is the manufacturer of ELECTROSURGICAL PROBE?

Smith & Nephew Endoscopy, Inc. filed the 510(k) submission for ELECTROSURGICAL PROBE (K963901).

What is the FDA product code for ELECTROSURGICAL PROBE?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ELECTROSURGICAL PROBE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ELECTROSURGICAL PROBE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Intended 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

Related Devices

K974516 — ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE · Endolap, Inc. · Dec 22, 1997
K972497 — KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES · KARL STORZ Endoscopy-America, Inc. · Aug 27, 1997
K070812 — DISPOSABLE LAPAROSCOPIC INSTRUMENT · Modern Medical Equipment Mfg., Ltd. · Sep 14, 2007
K030831 — LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS · Modern Medical Equipment Mfg., Ltd. · Jun 15, 2004
K033027 — SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 · Shining World Health Care Co., Ltd. · Aug 12, 2004

Submission Summary (Full Text)

{0} K96 3901 Smith & Nephew Endoscopy, Inc. 160 Dascomb Road Andover, MA 01810 U.S.A. Telephone (508) 470-2800 Fax (508) 470-2227 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 ACUFEX® BOYONICS® IMAGES™