Cleared Special

Ambu? aScope? 5 Uretero (Standard Deflection); Ambu? aScope? 5 Uretero (Reverse Deflection); Ambu? aView? 2 Advance

K242108 · Ambu A/S · Gastroenterology & Urology
Aug 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K242108 is an FDA 510(k) clearance for the Ambu? aScope? 5 Uretero (Standard Deflection); Ambu? aScope? 5 Uretero (Reverse Deflection); Ambu? aView? 2 Advance, a Ureteroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FGB), submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on August 16, 2024, 29 days after receiving the submission on July 18, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K242108 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FGB — Ureteroscope And Accessories, Flexible/rigid
Device Class Class II — 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).

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