Cleared Traditional

K845048 - NEPHROSTOMY DRAINAGE CATHETER & STIFFENER (FDA 510(k) Clearance)

K845048 · American Edwards Laboratories · Gastroenterology & Urology device
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Jan 1985
Decision
15d
Days
-
Risk

K845048 is an FDA 510(k) clearance for the NEPHROSTOMY DRAINAGE CATHETER & STIFFENER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on January 15, 1985 after a review of 15 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 American Edwards Laboratories devices

Submission Details

510(k) Number K845048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1984
Decision Date January 15, 1985
Days to Decision 15 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
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -