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Pancreatic Drainage Tube

by Aomori Olympus Co., Ltd.

510(k) K021672

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 NumberK021672 Date16 Apr 2003ClearedStatusActive

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  • Withdrawn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
FGE
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Pancreatic Drainage Tube is a medical device classified as a stent, drain, and dilator for the biliary ducts. It is designed to facilitate endoscopic pancreatic drainage when used in conjunction with Olympus endoscopes.

The device is intended for short-term implantation and is available as a kit that includes accessories and a guidewire to aid in placement. This product is regulated under FDA 510(k) clearance number K021672.

Other devices from Aomori Olympus Co., Ltd.

Questions

AI-generated answers, 25 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 primary purpose of the Pancreatic Drainage Tube?

    This device is designed to facilitate endoscopic pancreatic drainage. It functions as a stent, drain, and dilator for the biliary ducts to assist in clinical procedures.

  • How is the device supplied for clinical use?

    The device is supplied as a kit that includes the necessary accessories and a guidewire to assist the clinician with proper placement during the procedure.

  • Is this device intended for long-term implantation?

    No, the Pancreatic Drainage Tube is specifically intended for short-term implantation only.

  • What equipment is required to use this device?

    The Pancreatic Drainage Tube is designed to be used in conjunction with Olympus endoscopes to ensure proper functionality and placement.

  • What is the regulatory status of this device?

    This product is regulated under FDA 510(k) clearance number K021672, which signifies it has been reviewed and cleared for market distribution.