Karl Storz Endoscope Sterilization Trays, Models 39402AS, 39301HCTS, 39301BS

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

510(k) Number

K090818 ↗

FDA Product Code

KCT

Models / Variants

39402AS

39301HCTS

39301BS

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• KARL STORZ Laryngoscopes and Accessories

  Class II

  FDA 510(k) K252624 Active Cleared 15 May 2026

• Ksea Dion-Gracia Set

  Class II

  FDA 510(k) K010785 Active Cleared 21 Aug 2001

• Karl Storz Slotted Whisker Arthroscopic Blade

  Class II

  FDA 510(k) K963029 Active Cleared 27 Nov 1996

• Storz SLX-F2 Storm Touch

  Class II

  FDA 510(k) K070579 Active Cleared 30 Aug 2007

• Karl Storz Micro-Instrument for Cochlear Implantation

  Class I

  FDA 510(k) K946332 Active Cleared 5 Jun 1995

• Flexible Video-Uretero-Renoscope System Open recall

  Class II

  FDA 510(k) K131369 Active Cleared 26 Nov 2013

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

• What is the Karl Storz endoscope sterilization tray used for?

  The tray is designed for the storage, transport, cleaning, disinfection, and sterilization of endoscopic equipment, specifically flexible endoscopes including camera heads. It supports end-to-end workflows in professional healthcare settings by providing a reusable container system that maintains device integrity during reprocessing cycles.

• Is the Karl Storz sterilization tray supplied sterile or non-sterile, and is it reusable?

  The tray is supplied as a non-sterile, reusable container system. It is intended for multiple use cycles after proper cleaning, disinfection, and sterilization between uses, making it suitable for repeated deployment in clinical environments where endoscope reprocessing occurs.

• What endoscope lengths and external dimensions does the Karl Storz tray accommodate?

  The tray accommodates flexible endoscopes with a maximum working length of 95 cm. Its external dimensions are 550 mm in length, 260 mm in width, and 92 mm in height, providing a standardized footprint for compatibility with sterilization equipment and storage cabinets.

• What regulatory authorization covers the Karl Storz endoscope sterilization tray models 39402AS, 39301HCTS, and 39301BS?

  The device is authorized under FDA 510(k) clearance K090818 with product code KCT. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) submission, as indicated by the decision code SESE and clearance type Traditional in the authorization records.