Cleared Special

K111372 - TAL PALLINDROME (TM) SYMMETRIC TIP DUAL...

K111372 is the FDA 510(k) clearance for TAL PALLINDROME (TM) SYMMETRIC TIP DUAL... by Covidien. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Special 510(k) pathway after a 80-day FDA review.

K111372 · Covidien · Gastroenterology & Urology device
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Aug 2011
Decision
80d
Days
Class 2
Risk

K111372 is an FDA 510(k) clearance for the TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (T.... Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on August 4, 2011 after a review of 80 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K111372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 16, 2011
Decision Date August 04, 2011
Days to Decision 80 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MSD Catheter, Hemodialysis, 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 - MSD Catheter, Hemodialysis, Implanted

All 49
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