Cleared Traditional

K160766 - Ambu USR

K160766 is the FDA 510(k) clearance for Ambu USR by Ambu A/S. It is a Class 2 Gastroenterology & Urology device (product code FAJ) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K160766 · Ambu A/S · Gastroenterology & Urology device
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Aug 2016
Decision
149d
Days
Class 2
Risk

K160766 is an FDA 510(k) clearance for the Ambu USR, Ambu M. Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on August 17, 2016 after a review of 149 days - within the typical 510(k) review window.

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 K160766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2016
Decision Date August 17, 2016
Days to Decision 149 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
19d slower than avg
Panel avg: 130d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAJ Cystoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform 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 - FAJ Cystoscope And Accessories, Flexible/rigid

All 59
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K160766.
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MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
K090814 · Gyrus Acmi, Inc. · Apr 2009
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K051176 · Richard Wolf Medical Instruments Corp. · Oct 2005
STRYKER FLEXIBLE CYSTONEPHROSCOPE
K043022 · Stryker Endoscopy · Mar 2005