Ambu Duodeno System

by Ambu Innovation GmbH

510(k) K201098

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

510(k) K201098↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK201098	Date17 Jul 2020Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K201098
FDA Product Code: FDT

Device Class: Class II
Regulation: 21 CFR Part 876.1500
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Ambu Duodeno System is a medical device designed for use in gastrointestinal procedures, specifically duodenoscopy. It is intended to assist healthcare professionals in diagnostic and therapeutic interventions within the duodenum.

The device is supplied as a single-use product and is intended for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. It is cleared under FDA 510(k) regulation and is classified as a Class 2 device in the Gastroenterology and Urology specialty.