Product code MDA— General, Plastic Surgery
EPI-DERM SILICONE GEL SHEETING
- Classification name
- Elastomer, Silicone, For Scar Management
- Device class
- Class 1
- Regulation
- 21 CFR 878.4025
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 81
- First cleared
- Most recent
Market context for product code MDA
FDA has cleared devices under product code MDA between 1985 and 2011, filed by 52 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2011
- 2009
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
Top applicants under product code MDA
Recent clearances under product code MDA
- K112131 — NEODYNE DRESSING
- K111733 — CORELEADER SCAR-DIMMER
- K083718 — BEAU RX SCAR CARE GEL
- K053481 — KELO-COTE SPRAY
- K041704 — NEWGEL AND NEWGEL PLUS E
- K040307 — HANSON SCAR ADE
- K024057 — CURAD SCAR THERAPY
- K024160 — NEOSPORIN SCAR SOLUTION
- K023678 — DIMISIL SCAR GEL
- K023136 — OLEEVA FABRIC
- K014036 — MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.
- K013732 — GELZONE
- K012419 — CONFORM SHEETING, MODEL IGEL
- K010675 — ENSIL FABRIC
- K010245 — ACTIVHEAL SCAR MANAGEMENT DRESSING
- K003979 — MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD
- K003948 — EPI-DERM SILICONE GEL SHEETING
- K002488 — KELO-COTE TOPICAL GEL
- K002109 — OLEEVA FOAM
- K001608 — BLAINE SCARCARE PATCH
- K992522 — SPECTRUM DESIGNS SPECTRAGEL
- K991970 — SCAREASE SHEETS & SCAREASE GEL
- K991312 — SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
- K990651 — SKIN 2 FORTE SILICONE SHEETING
- K984029 — SILGEL STC-S
- K991968 — CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
- K992146 — SCARAID SILICONE GEL SHEETING
- K991957 — CICACARE MANAGEMENT FOR SCARS
- K991478 — TENDER TOUCH SILICONE GEL PADS
- K991630 — ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET
- K991604 — EPI-FOAM SILICONE SHEETING
- K981353 — AVOGEL
- K984213 — NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS
- K984115 — SCAREASE & SCAREASE ADHESIVE GEL
- K982036 — SILON SCAR STRIPS
- K982051 — KELOCATE SHEETING
- K981902 — SPENCO SILICONE GEL SHEET
- K981387 — EVANESCE SCAR MANAGEMENT SYSTEM
- K980563 — SKAR-KARE SHEET
- K974380 — REJUVENESS
- K974172 — SILGEL TOPICAL GEL SHEET
- K974143 — KMC NEWSKIN
- K974354 — MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE
- K973271 — SKAR-KARE
- K973572 — KELOCOTE SCAR GEL AND KELOCOTE LASER GEL
- K972597 — PMT NEW BEGINNINGS GELSHAPES & AMEND
- K971009 — SCAR CARE
- K971916 — MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL
- K971482 — DEGANIA SILICONE SIL-K
- K971468 — SCAR HEAL
- K970702 — SPECTRUM DESIGNS SPECTRAGEL
- K964846 — IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
- K963128 — NOVAGEL SILICONE GEL SHEETING
- K961410 — DURASIL (MODIFICATION)
- K962013 — MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
- K960254 — SILGEL TOPICAL GEL SHEET
- K955664 — STERILIZED TRI BLOCK POLYMER GEL SHEET
- K954413 — KELOCOTE
- K952612 — DURASIL
- K953420 — SILK*SKIN SCAR TREATMENT
- K952546 — SILON SILICONE TEXTILE COMPOSITE
- K946362 — SILON SILICONE FOAM SHEETING
- K945892 — SILON(R) SILICONE THERMOPLASTIC SHEETING
- K942339 — SKIN NEUVEAU SCAR TREATMENT
- K942695 — TRI BLOCK POLUMER GEL SHEETING
- K941197 — SILK*SKIN SCAR TREATMENT
- K942156 — EPI-DERM SILICONE GEL SHEETING
- K941125 — NOVAGEL SILICONE GEL SHEETING
- K933811 — MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST
- K925583 — JOBSKIN CONTINUING CARE
- K935499 — PMT SILICONE SHEETING
- K934829 — HASKON MEDICAL GRADE SHEETING
- K935803 — CICA-CARE SILICONE GEL SHEET
- K932048 — SILICONE GEL SHEETING
- K932214 — SILON SILICONE GEL SHEET
- K930409 — PMT(R) SILICONE GEL SHEETING MODEL 3505-1
- K914701 — SIL-K
- K913140 — SILICONE GEL SHEETING
- K901990 — VINYL SILICONE ELASTOMER MATERIAL
- K901991 — SILICONE ELASTOMER PUTTY
- K840113 — SILICONE SPLINTING MATERIAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.