Cleared Traditional

K844090 - PERCUTANEOUS NEPHROSTOMY TROCAR SYS (FDA 510(k) Clearance)

K844090 · American Edwards Laboratories · Gastroenterology & Urology device
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Dec 1984
Decision
44d
Days
-
Risk

K844090 is an FDA 510(k) clearance for the PERCUTANEOUS NEPHROSTOMY TROCAR SYS. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on December 5, 1984 after a review of 44 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 K844090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1984
Decision Date December 05, 1984
Days to Decision 44 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
86d faster than avg
Panel avg: 130d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -