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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 130d · 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 10
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
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
K020824 · Boston Scientific Corp · Apr 2002
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K000397 · Boston Scientific Corp · Mar 2000
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
K981669 · Boston Scientific Corp · Jun 1998
WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
K974018 · Wilson-Cook Medical, Inc. · Jan 1998