Cleared Traditional

CURITY SILICONE NEPHROSTOMY CATHETER (K842840) - FDA 510(k) Clearance

K842840 · The Kendal Co. · Gastroenterology & Urology device
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Oct 1984
Decision
76d
Days
-
Risk

K842840 is an FDA 510(k) clearance for the CURITY SILICONE NEPHROSTOMY CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by The Kendal Co. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 76 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.

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Submission Details

510(k) Number K842840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date October 04, 1984
Days to Decision 76 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
54d faster than avg
Panel avg: 130d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -