Tubular Electrode Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K992542 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Csm Stretta Control Module Electrosurgical Generator, Model S400

  Class II

  FDA 510(k) K991529 Active Cleared 14 Sep 1999

• Delivery Sheath

  Class II

  FDA 510(k) K983415 Active Cleared 1 Dec 1998

• Conway Stuart Model 100 Irrigation Pump & Accessories

  Class II

  FDA 510(k) K990724 Active Cleared 13 Aug 1999

• Csm Stretta System

  Class II

  FDA 510(k) K000245 Active Cleared 18 Apr 2000

• Electrosurgical Inflatable Basket Electrodes

  Class II

  FDA 510(k) K983116 Active Cleared 3 Dec 1998

• Stretta Inflatable Basket Catheter Electrode with Aspiration

  Class II

  FDA 510(k) K991291 Active Cleared 14 Jul 1999

See all devices from Conway Stuart Medical, Inc. →

• What is the primary function of the Tubular Electrode Device?

  The Tubular Electrode Device is an electrosurgical instrument intended for use in surgical procedures. Its primary function is to serve as an electrode to deliver electrical energy to target tissue during clinical applications.

• What is the regulatory status of this device?

  This device is identified under FDA 510(k) number K992542. It was determined to be substantially equivalent to existing devices through the traditional 510(k) premarket notification process.

• Who is the manufacturer of the Tubular Electrode Device?

  The device is manufactured by Conway Stuart Medical, Inc., located in Sunnyvale, California. The company submitted the device for review under the traditional 510(k) process, which resulted in a determination of substantial equivalence.