Cleared Traditional

K091519 - HAEMOBAND MULTI-LIGATOR

K091519 is an FDA 510(k) clearance for HAEMOBAND MULTI-LIGATOR, manufactured by Haemoband Surgical, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FHN cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K091519 · Haemoband Surgical, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
67d
Days
Class 2
Risk

K091519 is an FDA 510(k) clearance for the HAEMOBAND MULTI-LIGATOR. Classified as Ligator, Hemorrhoidal (product code FHN), Class II - Special Controls.

Submitted by Haemoband Surgical, Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on July 28, 2009 after a review of 67 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 Haemoband Surgical, Ltd. devices

FDA 510(k) Submission Details - K091519

510(k) Number K091519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 131d · This submission: 67d
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 19
Devices cleared under the same product code (FHN) and FDA review panel - the closest regulatory comparables to K091519.
Wi-3 HAL-RAR System
K150718 · Agency For Medical Innovations GmbH · Jun 2015
NEXUS HEMORRHOID LIGATOR
K131282 · Inx Medical · Jul 2013
THD BANDY
K093497 · Thd Spa · Jul 2010
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
K070881 · Sapimed S.P.A. · Sep 2007
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
K020824 · Boston Scientific Corp · Apr 2002
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
K020526 · Don Wilson/Wilson-Cook Medical, Inc. · Mar 2002