Cleared Traditional

MANAN GENERAL UTILITY DRAINAGE CATHETER (K980193) - FDA 510(k) Clearance

K980193 · Medical Device Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
127d
Days
-
Risk

K980193 is an FDA 510(k) clearance for the MANAN GENERAL UTILITY DRAINAGE CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Medical Device Technologies, Inc. (Gainsville, US). The FDA issued a Cleared decision on May 27, 1998 after a review of 127 days - within the typical 510(k) review window.

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 Medical Device Technologies, Inc. devices

Submission Details

510(k) Number K980193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1998
Decision Date May 27, 1998
Days to Decision 127 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 130d · This submission: 127d
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 K980193.
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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