Cleared Traditional

Wi-3 HAL-RAR System

K150718 · Agency For Medical Innovations GmbH · Gastroenterology & Urology
Jun 2015
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K150718 is an FDA 510(k) clearance for the Wi-3 HAL-RAR System, a Ligator, Hemorrhoidal (Class II — Special Controls, product code FHN), submitted by Agency For Medical Innovations GmbH (Feldkirch, AT). The FDA issued a Cleared decision on June 12, 2015, 85 days after receiving the submission on March 19, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.

Submission Details

510(k) Number K150718 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2015
Decision Date June 12, 2015
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FHN — Ligator, Hemorrhoidal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4400