Home / 510(k) Clearances / K050649

510(k) K050649

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2005
Date Received
March 14, 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)
  • K050726 — SILVERSEAL SILVERAID WITH X-STATIC (December 5, 2005)
  • K051256 — SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC (July 21, 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

  • 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)
  • K250890 — SBC1 Cream (January 12, 2026)
  • K252759 — revyve® Antimicrobial Skin and Wound Cleanser (January 8, 2026)
  • K251757 — Puracyn® Plus Antimicrobial Irrigation Solution (January 5, 2026)
  • K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber (December 19, 2025)
  • K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) (November 19, 2025)
  • K250115 — Hemastyl(™) Wound Dressing (October 14, 2025)