Cleared Traditional

AUTO-BAND LIGATOR (K031236) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031236 · Scandimed. A.S. · Gastroenterology & Urology device
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Nov 2003
Decision
210d
Days
Class 2
Risk

K031236 is an FDA 510(k) clearance for the AUTO-BAND LIGATOR. Classified as Ligator, Esophageal (product code MND), Class II - Special Controls.

Submitted by Scandimed. A.S. (Glostrop, DK). The FDA issued a Cleared decision on November 14, 2003 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Scandimed. A.S. devices

Submission Details

510(k) Number K031236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2003
Decision Date November 14, 2003
Days to Decision 210 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 130d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K031236.
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