Cleared Traditional

DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ (K853558) - FDA 510(k) Clearance

K853558 · American White Cross, Inc. · General & Plastic Surgery device
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Sep 1985
Decision
10d
Days
-
Risk

K853558 is an FDA 510(k) clearance for the DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ.

Submitted by American White Cross, Inc. (Stamford, US). The FDA issued a Cleared decision on September 5, 1985 after a review of 10 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 American White Cross, Inc. devices

Submission Details

510(k) Number K853558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date September 05, 1985
Days to Decision 10 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
105d faster than avg
Panel avg: 115d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -