KSEA Fiberscope

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K011793 ↗

FDA Product Code

LYK

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Karl Storz Endoscopy-America, Inc. →

• What is the KSEA Fiberscope used for in clinical practice?

  The KSEA Fiberscope is designed for internal visualization of body cavities and lumens, specifically within the gastrointestinal and urinary tracts. Its flexible shaft allows for navigation through complex anatomical pathways, making it suitable for diagnostic examinations and therapeutic interventions in gastroenterology and urology. This includes procedures where precise inspection and intervention are required, such as biopsies or the removal of obstructions.

• Is the KSEA Fiberscope a single-use or reusable device?

  The KSEA Fiberscope is a reusable medical instrument. After each use, it must undergo thorough cleaning, disinfection, and sterilization following established protocols to ensure safety and prevent cross-contamination between patients. Reusability is common for endoscopes when proper maintenance and sterilization procedures are strictly adhered to.

• What regulatory pathway does the KSEA Fiberscope follow?

  The KSEA Fiberscope has received FDA 510(k) clearance (K011793) as substantially equivalent to a predicate device. This clearance was granted under the FDA’s traditional review pathway, with the device classified under regulation 876.1500 and categorized as an angioscope. The advisory committee involved in its review was the Gastroenterology and Urology (GU) committee.

• How is the KSEA Fiberscope classified under FDA regulations?

  The KSEA Fiberscope is classified under FDA regulation 876.1500 and falls under the product code LYK. It is designated as a Class II device, which typically requires special controls to ensure its safety and effectiveness. The classification reflects its role as an angioscope, intended for internal visualization in medical procedures.

• Does the KSEA Fiberscope have any specific safety considerations for use in MRI environments?

  The available data for the KSEA Fiberscope does not specify any particular MRI safety classification. Clinicians should verify compatibility with their MRI equipment and follow manufacturer guidelines to ensure safe use in magnetic resonance imaging environments, as some endoscopes may contain metallic components that could pose risks.