Ksea Calcusplit

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K992114 ↗

FDA Product Code

FFK

Device Class

Class II

Regulation

21 CFR Part 876.4480

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Ksea Gaab Neuroendoscope and Chavantes-Zaamorano Neuroendoscope Sets

  Class II

  FDA 510(k) K982837 Active Cleared 6 Nov 1998

• Ksea Quadro Switch

  Class II

  FDA 510(k) K021776 Active Cleared 15 Aug 2002

• Autocon II 200 Electrosurgical Generator

  Class II

  FDA 510(k) K023924 Active Cleared 21 Feb 2003

• Ksea Plastic Trocars

  Class II

  FDA 510(k) K974366 Active Cleared 8 Jan 1998

• Ksea Culdocentesis Set

  Class II

  FDA 510(k) K962881 Active Cleared 22 Oct 1996

• Hand Extractor Hector

  Class II

  FDA 510(k) K953109 Active Cleared 25 Aug 1995

See all devices from Karl Storz Endoscopy →