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510(k) K981902

SPENCO SILICONE GEL SHEET by Spenco Medical Corp. — Product Code MDA

K981902 is an FDA 510(k) premarket notification submitted by Spenco Medical Corp. for the device "SPENCO SILICONE GEL SHEET". The FDA issued a decision of Substantially Equivalent on June 25, 1998. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Spenco Medical Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1998
Date Received
June 1, 1998
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 Spenco Medical Corp.

  • K922228 — 2ND SKIN STERILE ADHESIVE STRIP (December 11, 1992)
  • K911550 — 2ND SKIN MOIST BURN PADS WITH ALOE (September 6, 1991)
  • K910927 — SPENCIO SKIN GUARD KIT (June 3, 1991)
  • K896533 — SPENCO BREAST FORMS (December 13, 1989)
  • K894898 — 2ND SKIN NON-STICK MOIST BURN PADS (August 23, 1989)
  • K820906 — SPENCO CRYOPRESS (May 13, 1982)
  • K811184 — SPENCO DERMAL PADS (May 20, 1981)
  • K791726 — HYDROGEL-PREP (November 20, 1979)
  • K791162 — GELSKIN (September 4, 1979)

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