Cleared Traditional

K942156 - EPI-DERM SILICONE GEL SHEETING

K942156 is an FDA 510(k) clearance for EPI-DERM SILICONE GEL SHEETING, manufactured by Biodermis Corp.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K942156 · Biodermis Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 1994
Decision
41d
Days
Class 1
Risk

K942156 is an FDA 510(k) clearance for the EPI-DERM SILICONE GEL SHEETING. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Biodermis Corp. (Las Vegas, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - the FDA general and plastic surgery device framework. 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 Biodermis Corp. devices

FDA 510(k) Submission Details - K942156

510(k) Number K942156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1994
Decision Date June 13, 1994
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

MDA Device Classification - Class 1, General Controls

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MDA Elastomer, Silicone, For Scar Management

All 52
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K942156.
STERILIZED TRI BLOCK POLYMER GEL SHEET
K955664 · Silipos, Inc. · Feb 1996
SKIN NEUVEAU SCAR TREATMENT
K942339 · Puritas Health Care, Inc. · Nov 1994
SILK*SKIN SCAR TREATMENT
K941197 · Puritas Health Care, Inc. · Aug 1994
NOVAGEL SILICONE GEL SHEETING
K941125 · Brennen Medical, Inc. · May 1994
PMT SILICONE SHEETING
K935499 · Pmt Corp. · Feb 1994
CICA-CARE SILICONE GEL SHEET
K935803 · Smith & Nephew United, Inc. · Feb 1994