Cleared Special

K083556 - MODIFICATION TO AUTO-BAND LIGATOR

K083556 is an FDA 510(k) clearance for MODIFICATION TO AUTO-BAND LIGATOR, manufactured by Scandimed International. The device is a Class 2 Gastroenterology & Urology device with product code MND cleared through the Special 510(k) pathway after a 79-day FDA review.

K083556 · Scandimed International · Gastroenterology & Urology device
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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

FDA 510(k) Submission Details - K083556

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.

MND Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (MND) and FDA review panel - the closest regulatory comparables to K083556.
AUTOBAND LIGATOR
K132535 · Endochoice, Inc. · Aug 2013
INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321
K051950 · Ethicon Endo-Surgery, Inc. · Oct 2005
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
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K013066 · Olympus America, Inc. · Dec 2001
OLYMPUS ENDOSCOPIC LIGATION DEVICE
K001744 · Olympus America, Inc. · Feb 2001