Cleared Traditional

K110793 - AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 131d · 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 34
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K110793.
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NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
K090102 · C.R. Bard, Inc. · Feb 2009