Cleared Traditional

HAEMOBAND MULTI-LIGATOR

K091519 · Haemoband Surgical, Ltd. · Gastroenterology & Urology
Jul 2009
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K091519 is an FDA 510(k) clearance for the HAEMOBAND MULTI-LIGATOR, a Ligator, Hemorrhoidal (Class II — Special Controls, product code FHN), submitted by Haemoband Surgical, Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on July 28, 2009, 67 days after receiving the submission on May 22, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.

Submission Details

510(k) Number K091519 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2009
Decision Date July 28, 2009
Days to Decision 67 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