Cleared Traditional

NEPHROSTOMY SET (K862742) - FDA 510(k) Clearance

K862742 · Meadox Surgimed, Inc. · Gastroenterology & Urology device
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Oct 1986
Decision
102d
Days
-
Risk

K862742 is an FDA 510(k) clearance for the NEPHROSTOMY SET. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on October 31, 1986 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Meadox Surgimed, Inc. devices

Submission Details

510(k) Number K862742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1986
Decision Date October 31, 1986
Days to Decision 102 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
28d faster than avg
Panel avg: 130d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -