Cleared Traditional

K840401 - BIOPSY NEEDLES VARIOUS (FDA 510(k) Clearance)

K840401 · E-Z-Em, Inc. · General & Plastic Surgery device
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Mar 1984
Decision
41d
Days
-
Risk

K840401 is an FDA 510(k) clearance for the BIOPSY NEEDLES VARIOUS.

Submitted by E-Z-Em, Inc. (Walker, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K840401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1984
Decision Date March 12, 1984
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 114d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -