Cleared Special

MODIFICATION TO AUTO-BAND LIGATOR (K083556) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K083556 · Scandimed International · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
79d
Days
Class 2
Risk

K083556 is an FDA 510(k) clearance for the MODIFICATION TO AUTO-BAND LIGATOR. Classified as Ligator, Esophageal (product code MND), Class II - Special Controls.

Submitted by Scandimed International (Jamestown, US). The FDA issued a Cleared decision on February 19, 2009 after a review of 79 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Scandimed International devices

Submission Details

510(k) Number K083556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2008
Decision Date February 19, 2009
Days to Decision 79 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 130d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MND Ligator, Esophageal
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 - MND Ligator, Esophageal

All 14
Devices cleared under the same product code (MND) and FDA review panel - the closest regulatory comparables to K083556.
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K033245 · C.R. Bard, Inc. · Nov 2003
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K022434 · C.R. Bard, Inc. · Aug 2002
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K990864 · Boston Scientific Corp · Jun 1999
BARD RAPIDFIRE MULTIPLE BAND LIGATOR
K971137 · C.R. Bard, Inc. · Oct 1997
STIEGMANN-GOFF ENDOSCOPIC LIGATOR
K940661 · C.R. Bard, Inc. · Nov 1994