Cleared Traditional

SILON TRANSPARENT WOUND DRESSINGS (K923150) - FDA 510(k) Clearance

K923150 · Bio Med Sciences, Inc. · General & Plastic Surgery device
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Aug 1992
Decision
59d
Days
-
Risk

K923150 is an FDA 510(k) clearance for the SILON TRANSPARENT WOUND DRESSINGS. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Bio Med Sciences, Inc. (Bethlehem, US). The FDA issued a Cleared decision on August 27, 1992 after a review of 59 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 Bio Med Sciences, Inc. devices

Submission Details

510(k) Number K923150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1992
Decision Date August 27, 1992
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -