Cleared Traditional

K850287 - MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET (FDA 510(k) Clearance)

K850287 · Mentor Corp. · Gastroenterology & Urology device
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Mar 1985
Decision
42d
Days
-
Risk

K850287 is an FDA 510(k) clearance for the MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on March 7, 1985 after a review of 42 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 Mentor Corp. devices

Submission Details

510(k) Number K850287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1985
Decision Date March 07, 1985
Days to Decision 42 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 130d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 55
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