Cleared Traditional

K150718 - Wi-3 HAL-RAR System

K150718 is an FDA 510(k) clearance for Wi-3 HAL-RAR System, manufactured by Agency For Medical Innovations GmbH. The device is a Class 2 Gastroenterology & Urology device with product code FHN cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K150718 · Agency For Medical Innovations GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
85d
Days
Class 2
Risk

K150718 is an FDA 510(k) clearance for the Wi-3 HAL-RAR System. Classified as Ligator, Hemorrhoidal (product code FHN), Class II - Special Controls.

Submitted by Agency For Medical Innovations GmbH (Feldkirch, AT). The FDA issued a Cleared decision on June 12, 2015 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Agency For Medical Innovations GmbH devices

FDA 510(k) Submission Details - K150718

510(k) Number K150718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 131d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FHN Device Classification - Class 2, Special Controls

Product Code FHN Ligator, Hemorrhoidal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Acknowledge Regulatory Strategies
Allison C Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FHN Ligator, Hemorrhoidal

All 19
Devices cleared under the same product code (FHN) and FDA review panel - the closest regulatory comparables to K150718.
Multi-Band Ligator
K213223 · Beijing Zksk Technology Co., Ltd. · Jun 2022
Ligation Device
K172985 · Leo Medical Co., Ltd. · Jun 2018
NEXUS HEMORRHOID LIGATOR
K131282 · Inx Medical · Jul 2013
THD BANDY
K093497 · Thd Spa · Jul 2010
HAEMOBAND MULTI-LIGATOR
K091519 · Haemoband Surgical, Ltd. · Jul 2009
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
K070881 · Sapimed S.P.A. · Sep 2007