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MDA — Elastomer, Silicone, For Scar Management Class I

FDA Device Classification

FDA product code MDA covers "Elastomer, Silicone, For Scar Management", a Class I medical device regulated under 21 CFR 878.4025. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MDA
Device Class
Class I
Regulation Number
878.4025
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K112131neodyne biosciencesNEODYNE DRESSINGSeptember 29, 2011
K111733coreleader biotech coCORELEADER SCAR-DIMMERSeptember 22, 2011
K083718beau rx solutionsBEAU RX SCAR CARE GELJanuary 26, 2009
K053481advanced bio-technologiesKELO-COTE SPRAYApril 14, 2006
K041704newmedical technologyNEWGEL AND NEWGEL PLUS EOctober 17, 2005
K040307hanson medicalHANSON SCAR ADEAugust 12, 2004
K024057beiersdorfCURAD SCAR THERAPYJune 18, 2003
K024160warner-lambertNEOSPORIN SCAR SOLUTIONMarch 17, 2003
K023678aesthetic and reconstructive technologiesDIMISIL SCAR GELJanuary 23, 2003
K023136bio med sciencesOLEEVA FABRICOctober 16, 2002
K014036medtrade productsMEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICFebruary 14, 2002
K013732implantech associatesGELZONEFebruary 7, 2002
K012419implantech associatesCONFORM SHEETING, MODEL IGELOctober 24, 2001
K010675gottfried medicalENSIL FABRICMay 30, 2001
K010245advanced medical solutionsACTIVHEAL SCAR MANAGEMENT DRESSINGApril 25, 2001
K003979medtrade productsMEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PADMarch 19, 2001
K003948biodermisEPI-DERM SILICONE GEL SHEETINGJanuary 29, 2001
K002488advanced bio-technologiesKELO-COTE TOPICAL GELJanuary 5, 2001
K002109bio med sciencesOLEEVA FOAMAugust 31, 2000
K001608blaine labsBLAINE SCARCARE PATCHJuly 25, 2000

FDA data resources