510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071185Substantially Equivalent

Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode

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

K071185 is the FDA 510(k) clearance record for MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, a class II device, cleared for Ambu A/S on under FDA product code GXZ (Electrode, Needle). FDA records list 13 510(k) clearances for Ambu A/S, from to . As of , FDA records show no recalls naming K071185.

Clearance record

Decision date
Received
(30 days to decision)
Product code
GXZ Electrode, Needle
Regulation
21 CFR 882.1350
Device class
Class II
Review panel
Neurology
Applicant
Ambu A/S 6740 Baymeadow Dr., Glen Burnie MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXZ

Trailing 12 months

FDA records hold no clearances under product code GXZ in the trailing twelve months.

FDA records show no clearances under product code GXZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260