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510(k) K050726

SILVERSEAL SILVERAID WITH X-STATIC by Noble Fiber Technologies, Inc. — Product Code FRO

K050726 is an FDA 510(k) premarket notification submitted by Noble Fiber Technologies, Inc. for the device "SILVERSEAL SILVERAID WITH X-STATIC". The FDA issued a decision of Substantially Equivalent on December 5, 2005. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Noble Fiber Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2005
Date Received
March 18, 2005
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, Inc.

  • K063190 — SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC (August 21, 2007)
  • 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)
  • K033900 — X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING (January 14, 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