Wi-3 HAL-RAR System

FDA 510(k) K150718 · Agency For Medical Innovations GmbH

Substantially Equivalent

510(k) numberK150718

Submission

Device name
Wi-3 HAL-RAR System
Applicant
Agency For Medical Innovations GmbH
Feldkirch, AT
Received
March 19, 2015
Decision date
June 12, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FHN – Ligator, Hemorrhoidal
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4400
Specialty
Gastroenterology, Urology

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Questions and answers

When was Wi-3 HAL-RAR System cleared by the FDA?

Wi-3 HAL-RAR System (K150718) received a 510(k) decision of Substantially Equivalent on June 12, 2015, 85 days after the submission was received.

What is the product code of K150718?

The FDA product code is FHN – Ligator, Hemorrhoidal, a Class II (moderate risk) device regulated under 21 CFR 876.4400.