Cleared Traditional

K233630 - Ambu aScope 5 Uretero (Standard Deflect...

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

K233630 is the FDA 510(k) clearance for Ambu aScope 5 Uretero (Standard Deflect... by Ambu A/S. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K233630 · Ambu A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
224d
Days
Class 2
Risk

K233630 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 June 24, 2024 after a review of 224 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ambu A/S devices

Submission Details

510(k) Number K233630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2023
Decision Date June 24, 2024
Days to Decision 224 days
Submission Type Traditional
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
94d slower than avg
Panel avg: 130d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 84
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K233630.
Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
K233778 · Zhuhai Pusen Medical Technology Co., Ltd. · Jul 2024
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000)
K241598 · Boston Scientific Corporation · Jul 2024
Single-use Video Ureterorenoscope (SVU-220US)
K241639 · Huger Medical Instrument Co., Ltd. · Jul 2024
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
K232911 · Karl Storz Endovision, Inc. · Jun 2024
Ureterorenoscope System
K240374 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · May 2024
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard)
K233275 · Gyrus Acmi, Inc. · Mar 2024