Cleared Special

K242108 - Ambu aScope 5 Uretero (Standard Deflection)

Also marketed or referenced as:
Ambu® aScope™ 5 Uretero (Reverse Deflection) Ambu® aView™ 2 Advance

K242108 is an FDA 510(k) clearance for Ambu aScope 5 Uretero (Standard Deflection), manufactured by Ambu A/S. The device is a Class 2 Gastroenterology & Urology device with product code FGB cleared through the Special 510(k) pathway after a 29-day FDA review.

K242108 · Ambu A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
29d
Days
Class 2
Risk

K242108 is an FDA 510(k) clearance for the Ambu® aScope™ 5 Uretero (Standard Deflection). Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on August 16, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ambu A/S devices

FDA 510(k) Submission Details - K242108

510(k) Number K242108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2024
Decision Date August 16, 2024
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FGB Device Classification - Class 2, Special Controls

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Ambu, Inc.
Sanjay Parikh

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FGB Ureteroscope And Accessories, Flexible/rigid

All 89
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K242108.
Video Ureteroscope System
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K233778 · Zhuhai Pusen Medical Technology Co., Ltd. · Jul 2024