Cleared Special

K023136 - OLEEVA FABRIC

K023136 is an FDA 510(k) clearance for OLEEVA FABRIC, manufactured by Bio Med Sciences, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Special 510(k) pathway after a 26-day FDA review.

K023136 · Bio Med Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
26d
Days
Class 1
Risk

K023136 is an FDA 510(k) clearance for the OLEEVA FABRIC. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Bio Med Sciences, Inc. (Allentown, US). The FDA issued a Cleared decision on October 16, 2002 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K023136

510(k) Number K023136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2002
Decision Date October 16, 2002
Days to Decision 26 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 79
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K023136.
CURAD SCAR THERAPY
K024057 · Beiersdorf, Inc. · Jun 2003
NEOSPORIN SCAR SOLUTION
K024160 · Warner-Lambert Co. · Mar 2003
DIMISIL SCAR GEL
K023678 · Aesthetic and Reconstructive Technologies, Inc. · Jan 2003
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.
K014036 · Medtrade Products , Ltd. · Feb 2002
GELZONE
K013732 · Implantech Associates, Inc. · Feb 2002
CONFORM SHEETING, MODEL IGEL
K012419 · Implantech Associates, Inc. · Oct 2001
K023136 · OLEEVA FABRIC
Download PDF FDA Summary Bio Med Sciences, Inc.