Cleared Traditional

MANAN UNIVERSAL SUMP DRAINAGE CATHETER (K953601) - FDA 510(k) Clearance

K953601 · Manan Medical Products, Inc. · Gastroenterology & Urology device
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Mar 1996
Decision
237d
Days
-
Risk

K953601 is an FDA 510(k) clearance for the MANAN UNIVERSAL SUMP DRAINAGE CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on March 26, 1996 after a review of 237 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Manan Medical Products, Inc. devices

Submission Details

510(k) Number K953601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1995
Decision Date March 26, 1996
Days to Decision 237 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
107d slower than avg
Panel avg: 130d · This submission: 237d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 18
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K953601.
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
K080944 · C.R. Bard, Inc. · Oct 2008
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
K063632 · C.R. Bard, Inc. · Jan 2007
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
K051316 · C.R. Bard, Inc. · Jul 2005
DILATATION CATHETER, BALLOON
K952968 · Boston Scientific Corp · Aug 1995