KSEA Vaporization Electrodes

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

510(k) Number

K961702 ↗

FDA Product Code

FAS

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Trocars, Cannulae, Sheaths, Obturators

  Class II

  FDA 510(k) K943697 Active Cleared 14 Sep 1994

• Trocars, Cannulae, Sheaths

  Class II

  FDA 510(k) K943816 Active Cleared 24 Aug 1994

• Ksea Instrument Set for Saphenous Vein Harvesting

  Class II

  FDA 510(k) K973068 Active Cleared 7 Nov 1997

• Luer, Jackson Trachea Tubes, Luer Speaking Trachea Tubes

  Class II

  FDA 510(k) K953368 Active Cleared 18 Sep 1995

• Ksea Semm Tissur Punch

  Class II

  FDA 510(k) K943053 Active Cleared 21 Mar 1995

• Cholangiography Set

  Class II

  FDA 510(k) K943435 Active Cleared 7 Nov 1994

See all devices from Karl Storz Endoskop GmbH →

• What is the intended use of the KSEA Vaporization Electrodes?

  The KSEA Vaporization Electrodes are intended for use in gastroenterology and urology settings as endoscopic electrodes for electrosurgical procedures, based on their classification as active urological electrodes.

• How are the KSEA Vaporization Electrodes supplied and are they sterile or reusable?

  The KSEA Vaporization Electrodes are supplied as non-sterile and are designed for reuse, meaning they must be cleaned and sterilized by the user before each procedure.

• What regulatory pathway was used to clear the KSEA Vaporization Electrodes?

  The KSEA Vaporization Electrodes were cleared via the traditional 510(k) pathway, demonstrating substantial equivalence to a predicate device under regulation number 876.4300.