Cleared Traditional

MANAN NEPHROSTOMY DRAINAGE CATHETER (K953547) - FDA 510(k) Clearance

K953547 · Manan Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
33d
Days
-
Risk

K953547 is an FDA 510(k) clearance for the MANAN NEPHROSTOMY DRAINAGE CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on August 30, 1995 after a review of 33 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Manan Medical Products, Inc. devices

Submission Details

510(k) Number K953547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1995
Decision Date August 30, 1995
Days to Decision 33 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
97d faster than avg
Panel avg: 130d · This submission: 33d
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 K953547.
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