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510(k) K991970

SCAREASE SHEETS & SCAREASE GEL by Pillar Surgical — Product Code MDA

K991970 is an FDA 510(k) premarket notification submitted by Pillar Surgical for the device "SCAREASE SHEETS & SCAREASE GEL". The FDA issued a decision of Substantially Equivalent on October 25, 1999. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Pillar Surgical has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1999
Date Received
June 11, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elastomer, Silicone, For Scar Management
Device Class
Class I
Regulation Number
878.4025
Review Panel
SU
Submission Type

Other clearances by Pillar Surgical

  • K002633 — SILMAX PECTORAL IMPLANT (November 21, 2000)
  • K002629 — SILMAX CONTOUR CARVING BLOCK IMPLANT (November 20, 2000)
  • K992239 — PILLAR CHIN IMPLANT (November 22, 1999)
  • K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (November 22, 1999)
  • K992240 — PILLAR MALAR IMPLANT (November 22, 1999)
  • K954382 — PROLASTIC SHEETING (November 29, 1995)

Other clearances for product code MDA

  • K112131 — NEODYNE DRESSING (September 29, 2011)
  • K111733 — CORELEADER SCAR-DIMMER (September 22, 2011)
  • K083718 — BEAU RX SCAR CARE GEL (January 26, 2009)
  • K053481 — KELO-COTE SPRAY (April 14, 2006)
  • K041704 — NEWGEL AND NEWGEL PLUS E (October 17, 2005)
  • K040307 — HANSON SCAR ADE (August 12, 2004)
  • K024057 — CURAD SCAR THERAPY (June 18, 2003)
  • K024160 — NEOSPORIN SCAR SOLUTION (March 17, 2003)
  • K023678 — DIMISIL SCAR GEL (January 23, 2003)
  • K023136 — OLEEVA FABRIC (October 16, 2002)

FDA data resources