510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191080Substantially Equivalent

Ambu aScope 4 RhinoLaryngo Slim

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

K191080 is the FDA 510(k) clearance record for Ambu aScope 4 RhinoLaryngo Slim, a class II device, cleared for Ambu A/S on under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)). FDA's definition for product code EOB reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 27 510(k) clearances for Ambu A/S, from to . As of , FDA records show no recalls naming K191080.

Clearance record

Decision date
Received
(28 days to decision)
Product code
EOB Nasopharyngoscope (Flexible Or Rigid)
Regulation
21 CFR 874.4760
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Ambu A/S Baltorpbakken 13, Ballerup, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EOB

Trailing 12 months
5 clearances under product code EOB in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EOB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20262
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260