Cleared Traditional

NEXUS HEMORRHOID LIGATOR

K131282 · Inx Medical · Gastroenterology & Urology

Jul 2013

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K131282 is an FDA 510(k) clearance for the NEXUS HEMORRHOID LIGATOR, a Ligator, Hemorrhoidal (Class II — Special Controls, product code FHN), submitted by Inx Medical (Chesterfield, US). The FDA issued a Cleared decision on July 11, 2013, 66 days after receiving the submission on May 6, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.

Submission Details

510(k) Number	K131282 FDA.gov
FDA Decision	Cleared 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