← Product Code [FAS](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS) · K970717

# VAPOR-TECH SLED ELECTRODE (K970717)

_Northgate Technologies, Inc. · FAS · May 8, 1997 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS/K970717

## Device Facts

- **Applicant:** Northgate Technologies, Inc.
- **Product Code:** [FAS](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS.md)
- **Decision Date:** May 8, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4300
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **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.

## Regulatory 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)

## Submission Summary (Full Text)

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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
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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS/K970717](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS/K970717)

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