Cleared Traditional

K833008 - PERCUTANEOUS NEPHROSTOMY CATHETER (FDA 510(k) Clearance)

K833008 · Medical Engineering Corp. · Gastroenterology & Urology device
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Oct 1983
Decision
43d
Days
-
Risk

K833008 is an FDA 510(k) clearance for the PERCUTANEOUS NEPHROSTOMY CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Medical Engineering Corp. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1983 after a review of 43 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 Medical Engineering Corp. devices

Submission Details

510(k) Number K833008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1983
Decision Date October 19, 1983
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
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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