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510(k) K012419

CONFORM SHEETING, MODEL IGEL by Implantech Associates, Inc. — Product Code MDA

K012419 is an FDA 510(k) premarket notification submitted by Implantech Associates, Inc. for the device "CONFORM SHEETING, MODEL IGEL". The FDA issued a decision of Substantially Equivalent on October 24, 2001. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Implantech Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2001
Date Received
July 30, 2001
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 Implantech Associates, Inc.

  • K200610 — Customized Contour Implant (December 23, 2020)
  • K191130 — Customized Contour Implant (August 23, 2019)
  • K172389 — ePTFE-Coated Auricular Implant (July 18, 2018)
  • K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, S (July 10, 2014)
  • K071470 — IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX (August 31, 2007)
  • K052505 — CALF IMPLANT, MODEL EC17-X (November 4, 2005)
  • K052504 — GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X (November 4, 2005)
  • K013732 — GELZONE (February 7, 2002)
  • K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) (November 24, 2000)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)

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