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510(k) K033900

X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING by Noble Fiber Technologies — Product Code FRO

K033900 is an FDA 510(k) premarket notification submitted by Noble Fiber Technologies for the device "X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING". The FDA issued a decision of Substantially Equivalent on January 14, 2005. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Noble Fiber Technologies has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2005
Date Received
December 17, 2003
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 Noble Fiber Technologies

  • K063190 — SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC (August 21, 2007)
  • K050726 — SILVERSEAL SILVERAID WITH X-STATIC (December 5, 2005)
  • K051256 — SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC (July 21, 2005)
  • K050649 — SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC (June 13, 2005)
  • K043526 — SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (March 10, 2005)
  • K033587 — SILVERSEAL (August 5, 2004)
  • K040019 — SILVERSEAL (July 23, 2004)

Other clearances for product code FRO

  • 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)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources