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KARL STORZ -ENDOSCOPE STERILIZATION TRAYS - 39402AS

by Karl Storz Endoscopy-America, Inc.

510(k) K090818

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090818 Date18 Aug 2009ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KCT
Models / Variants
39402AS
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is an endoscope sterilization tray designed for the storage and sterilization of endoscopic equipment. It is a reusable container system intended for use with flexible endoscopes, including camera heads, and supports transport, sterilization, and storage processes.

Supplied as a non-sterile, reusable tray, the device is used in professional healthcare settings for cleaning, disinfection, and sterilization workflows. It is authorized under FDA 510(k) clearance K090818 with product code KCT and is manufactured by Karl Storz Endoscopy-America, Inc. The tray accommodates endoscopes up to a maximum working length of 95 cm and has external dimensions of 550 x 260 x 92 mm.

Other devices from Karl Storz Endoscopy-America, Inc.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.