510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K233630Substantially Equivalent

Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2

Ambu A/S, Ballerup, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233630 is the FDA 510(k) clearance record for Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2, a class II device, cleared for Ambu A/S on under FDA product code FGB (Ureteroscope And Accessories, Flexible/Rigid). FDA's definition for product code FGB reads: "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)...". FDA records list 27 510(k) clearances for Ambu A/S, from to . As of , FDA records show no recalls naming K233630.

Clearance record

Decision date
Received
(224 days to decision)
Product code
FGB Ureteroscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ambu A/S Baltorpbakken 13, Ballerup, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FGB

Trailing 12 months
11 clearances under product code FGB in the twelve months to October 2026, August 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FGB, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20261
August 20263
September 20262
October 20260