Cleared Traditional

K981365 - MAHURKAR 13.5 FR CUFFED CATHETER WITH C...

K981365 is the FDA 510(k) clearance for MAHURKAR 13.5 FR CUFFED CATHETER WITH C... by Sherwood Medical Co.. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K981365 · Sherwood Medical Co. · Gastroenterology & Urology device
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Nov 1998
Decision
224d
Days
Class 2
Risk

K981365 is an FDA 510(k) clearance for the MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Bothell, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 224 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.

View all Sherwood Medical Co. devices

Submission Details

510(k) Number K981365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1998
Decision Date November 25, 1998
Days to Decision 224 days
Submission Type Traditional
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
94d slower than avg
Panel avg: 130d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 63
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