KSEA Spinoscope

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K023187 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K982837 Active Cleared 6 Nov 1998

• Ksea Quadro Switch

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  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 →

• What is the KSEA Spinoscope used for?

  The KSEA Spinoscope is used in orthopedic settings as a fiber optic endoscope with a remote eyepiece, functioning as a Class II surgical microscope for visualization during procedures.

• How is the KSEA Spinoscope supplied and is it reusable?

  The KSEA Spinoscope is a reusable fiber optic endoscope designed for multiple uses after proper cleaning and sterilization, as indicated by its classification as a surgical microscope intended for repeated clinical use.

• What regulatory pathway was used for the KSEA Spinoscope?

  The KSEA Spinoscope received FDA 510(k) clearance under K-number K023187 in 2002, following a traditional review process and evaluation by the Orthopedic advisory committee.