Cleared Traditional

K923150 - SILON TRANSPARENT WOUND DRESSINGS

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

FDA 510(k) Submission Details - K923150

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.

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 K923150.
CUTIFILM(R) FILM
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HYDRASORB STERILE DRESSING
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EPI-LOCK WOUND DRESSING
K926034 · Calgon Vestal Div. · Apr 1993
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