Cleared Traditional

K912032 - SILON(TM) TRANSPARENT WOUND DRESSING

K912032 · Bio Med Sciences, Inc. · General & Plastic Surgery device
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Aug 1991
Decision
104d
Days
-
Risk

K912032 is an FDA 510(k) clearance for the SILON(TM) TRANSPARENT WOUND DRESSING. 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 20, 1991 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio Med Sciences, Inc. devices

FDA 510(k) Submission Details - K912032

510(k) Number K912032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1991
Decision Date August 20, 1991
Days to Decision 104 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
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

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

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 49
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K912032.
DEROYAL TRANSPARENT FILM DRESSIGN
K920796 · Deroyal Industries, Inc. · Jul 1992
PROCEL BURN COVER
K915695 · W.L. Gore & Associates, Inc. · May 1992
CURITY VENTED DRESSING SYSTEM
K915635 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1992
INTRASITE HYDROCOLLOID WOUND DRESSING
K911660 · Smith & Nephew United, Inc. · Jun 1991