Cleared Traditional

K131282 - NEXUS HEMORRHOID LIGATOR

K131282 is an FDA 510(k) clearance for NEXUS HEMORRHOID LIGATOR, manufactured by Inx Medical. The device is a Class 2 Gastroenterology & Urology device with product code FHN cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K131282 · Inx Medical · Gastroenterology & Urology device
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Jul 2013
Decision
66d
Days
Class 2
Risk

K131282 is an FDA 510(k) clearance for the NEXUS HEMORRHOID LIGATOR. Classified as Ligator, Hemorrhoidal (product code FHN), Class II - Special Controls.

Submitted by Inx Medical (Chesterfield, US). The FDA issued a Cleared decision on July 11, 2013 after a review of 66 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 Inx Medical devices

FDA 510(k) Submission Details - K131282

510(k) Number K131282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2013
Decision Date July 11, 2013
Days to Decision 66 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
65d faster than avg
Panel avg: 131d · This submission: 66d
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 Peers - FHN Ligator, Hemorrhoidal

All 16
Devices cleared under the same product code (FHN) and FDA review panel - the closest regulatory comparables to K131282.
Multi-Band Ligator
K213223 · Beijing Zksk Technology Co., Ltd. · Jun 2022
Ligation Device
K172985 · Leo Medical Co., Ltd. · Jun 2018
Wi-3 HAL-RAR System
K150718 · Agency For Medical Innovations GmbH · Jun 2015
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