510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212382Substantially Equivalent

Ambu® aScope™ Gastro, Ambu® aBox™2

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

K212382 is the FDA 510(k) clearance record for Ambu® aScope™ Gastro, Ambu® aBox™2, a class II device, cleared for Ambu A/S on under FDA product code FDS (Gastroscope And Accessories, Flexible/Rigid). FDA's definition for product code FDS reads: "To examine or perform procedures in the stomach. 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...". FDA records list 27 510(k) clearances for Ambu A/S, from to . As of , FDA records show no recalls naming K212382.

Clearance record

Decision date
Received
(185 days to decision)
Product code
FDS Gastroscope 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 FDS

Trailing 12 months
8 clearances under product code FDS 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 FDS, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20260
April 20261
May 20260
June 20260
July 20260
August 20263
September 20261
October 20260