Home / 510(k) Clearances / K894898

510(k) K894898

2ND SKIN NON-STICK MOIST BURN PADS by Spenco Medical Corp. — Product Code FRO

K894898 is an FDA 510(k) premarket notification submitted by Spenco Medical Corp. for the device "2ND SKIN NON-STICK MOIST BURN PADS". The FDA issued a decision of Substantially Equivalent on August 23, 1989. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Spenco Medical Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1989
Date Received
August 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Spenco Medical Corp.

  • K981902 — SPENCO SILICONE GEL SHEET (June 25, 1998)
  • 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)
  • 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 FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (September 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (August 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (August 11, 2026)
  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)

FDA data resources