← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K981589

# ELECTROSURGICAL BASKET ELECTRODES                               ELECTROSURGICAL BASKET ELECTRODES (K981589)

_Conway Stuart Medical, Inc. · GEI · Jul 30, 1998 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K981589

## Device Facts

- **Applicant:** Conway Stuart Medical, Inc.
- **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md)
- **Decision Date:** Jul 30, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

## Device Story

Electrosurgical Basket Electrodes used for tissue coagulation. Device consists of basket-shaped electrode configuration; operates via electrosurgical energy delivery to target tissue. Used in clinical settings by qualified medical personnel trained in electrosurgery. Output provides controlled thermal effect on tissue to achieve coagulation. Benefits include precise tissue management during surgical procedures.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Electrosurgical basket electrode design. Energy source: electrosurgical generator (not specified). Device is a sterile, single-use or reusable (not specified) surgical instrument.

## Regulatory 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.

## Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 1998

Thomas C. Wehman, Ph.D. Conway Stuart Medical, Inc. 735 Palomar Avenue Sunnyvale, California 94086

K981589 Re: Trade Name: Electrosurgical Basket Electrodes Regulatory Class: II Product Code: GEI Dated: April 26, 1998 Received: May 4, 1998

Dear Dr. Wehman:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market these devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

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Page 2 - Thomas C. Wehman, Ph.D.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known).

K481589

Device Name:

Indications for Use:

Conway Stuart Medical Basket electrodes

Indicated for coagulation of tissue

These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

## (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE, IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |                                                                                                       |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Prescription Use<br>(per 21 CFR 801.109)               | <span style="text-decoration: overline;">✓</span> OR Over-the-Counter Use<br>(Optional format 1-2-06) |

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K981589 |
|---------------|---------|
|---------------|---------|

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Conway Stuart Medical, Inc.

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