510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150718Substantially Equivalent

Wi-3 HAL-RAR System

Agency for Medical Innovations Inc., Feldkirch, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150718 is the FDA 510(k) clearance record for Wi-3 HAL-RAR System, a class II device, cleared for Agency For Medical Innovations GmbH on under FDA product code FHN (Ligator, Hemorrhoidal). FDA records list 5 510(k) clearances for Agency For Medical Innovations GmbH, from to . As of , FDA records show no recalls naming K150718.

Clearance record

Decision date
Received
(85 days to decision)
Product code
FHN Ligator, Hemorrhoidal
Regulation
21 CFR 876.4400
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Agency For Medical Innovations GmbH Im Letten 1, Feldkirch, AT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FHN

Trailing 12 months

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

FDA records show no clearances under product code FHN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FHN, 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