Cleared Traditional

K842001 - LIVER BIOPSY TRAY (FDA 510(k) Clearance)

K842001 · Jayco Pharmaceuticals · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
152d
Days
-
Risk

K842001 is an FDA 510(k) clearance for the LIVER BIOPSY TRAY.

Submitted by Jayco Pharmaceuticals (Walker, US). The FDA issued a Cleared decision on October 15, 1984 after a review of 152 days - an extended review 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: 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 Jayco Pharmaceuticals devices

Submission Details

510(k) Number K842001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1984
Decision Date October 15, 1984
Days to Decision 152 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
22d slower than avg
Panel avg: 130d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -