Cleared Traditional

K844462 - DOSIMETRIC RELEASE IN THE PROCESSING OF GAMMA STER (FDA 510(k) Clearance)

K844462 · Washington-Greene County Branch Pennsylvania Assoc · General & Plastic Surgery device
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Dec 1984
Decision
27d
Days
-
Risk

K844462 is an FDA 510(k) clearance for the DOSIMETRIC RELEASE IN THE PROCESSING OF GAMMA STER.

Submitted by Washington-Greene County Branch Pennsylvania Assoc (Washington, US). The FDA issued a Cleared decision on December 12, 1984 after a review of 27 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.

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Submission Details

510(k) Number K844462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1984
Decision Date December 12, 1984
Days to Decision 27 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
87d faster than avg
Panel avg: 114d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -