Who is the manufacturer of VAPOR-TECH SLED ELECTRODE?

Northgate Technologies, Inc. filed the 510(k) submission for VAPOR-TECH SLED ELECTRODE (K970717).

What is the FDA product code for VAPOR-TECH SLED ELECTRODE?

FAS. It is classified under 21 CFR 876.4300 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for VAPOR-TECH SLED ELECTRODE?

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

Who can help prepare an FDA 510(k) submission like VAPOR-TECH SLED ELECTRODE?

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.

VAPOR-TECH SLED ELECTRODE

K970717 · Northgate Technologies, Inc. · FAS · May 8, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K970717
Device Name	VAPOR-TECH SLED ELECTRODE
Applicant	Northgate Technologies, Inc.
Product Code	FAS · Gastroenterology, Urology
Decision Date	May 8, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Northgate Technologies Inc. Resectoscope Sled™ Electrodes are intended to be used for resection/coagulation of urinary tract soft tissue.

Device Story

Electrosurgical electrode; designed for use with major brands of resectoscopes; used for resection and coagulation of urinary tract soft tissue; operated by urologists in clinical/surgical settings; provides electrosurgical energy delivery to target tissue; facilitates tissue removal and hemostasis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical electrode; non-toxic materials previously used in medical devices; compatible with standard resectoscopes; energy-based tissue resection/coagulation.

Indications for Use

Indicated for resection and coagulation of urinary tract soft tissue in patients requiring urological surgical procedures.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Reference Devices

Circon/ACMI (similar devices)
Greenwald Surgical Company, Inc. (similar devices)

Related Devices

K954710 — VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. · Northgate Technologies, Inc. · Apr 24, 1996
K973820 — USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE · Circon Corp. · May 12, 1998
K962538 — BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) · C.R. Bard, Inc. · Dec 17, 1996
K961702 — KSEA VAPORIZATION ELECTRODES · Karl Storz Endoskop GmbH · Aug 29, 1996
K961841 — BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) · C.R. Bard, Inc. · Oct 9, 1996

Submission Summary (Full Text)

{0} K970717 # EXHIBIT #5 ## (PREVIOUSLY EXHIBIT #6) ### SUMMARY OF SAFETY AND EFFECTIVENESS **Common/Usual Name:** Resectoscope Sled™ Electrode **Proprietary Name:** Vapor-Tech Sled™ Electrosurgical Electrode **Classification:** CLASS II **MAY - 8 1997** ### Materials: All materials used to manufacture the Northgate Technologies Inc. Electrodes are non-toxic and have been previously used to manufacture other medical devices. ### Description: Northgate’s Resectoscope Sled™ Electrode is designed to be used with most major brands of Resectoscopes. The electrodes are used for resection/coagulation of urinary tract soft tissue. ### Substantial Equivalence: Northgate’s Resectoscope Sled™ Electrodes are substantially equivalent in design, materials, and intended use to numerous currently marketed devices. Other manufacturers of similar devices are Circon/ACMI and the Greenwald Surgical Company, Inc. ### Intended Use: Northgate Technologies Inc. Resectoscope Sled™ Electrodes are intended to be used for resection/coagulation of urinary tract soft tissue. Northgate Technologies Incorporated 600 Church Road, Elgin, IL 60123 1-800-348-0424 IL: 847-608-8900 FAX: 847-608-9405 17