Cleared Traditional

K110793 - AMECATH AND AMECATH UNIQATH SOFT SHORT ...

K110793 is an FDA 510(k) clearance for AMECATH AND AMECATH UNIQATH SOFT SHORT ..., manufactured by Ameco Medical Industries. The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K110793 · Ameco Medical Industries · Gastroenterology & Urology device
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Dec 2011
Decision
269d
Days
Class 2
Risk

K110793 is an FDA 510(k) clearance for the AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION.... Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Ameco Medical Industries (Mason, US). The FDA issued a Cleared decision on December 16, 2011 after a review of 269 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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.

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FDA 510(k) Submission Details - K110793

510(k) Number K110793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2011
Decision Date December 16, 2011
Days to Decision 269 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
139d slower than avg
Panel avg: 130d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPB Device Classification - Class 2, Special Controls

Product Code MPB Catheter, Hemodialysis, Non-implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - MPB Catheter, Hemodialysis, Non-implanted

All 29
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K110793.
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MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
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NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
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NIAGARA TEMPORARY DUAL LUMEN CATHETERS
K030268 · C.R. Bard, Inc. · Jul 2003