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510(k) K012816

DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 by Dynarex Corp. — Product Code FRO

K012816 is an FDA 510(k) premarket notification submitted by Dynarex Corp. for the device "DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414". The FDA issued a decision of Substantially Equivalent on October 17, 2002. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Dynarex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2002
Date Received
August 22, 2001
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 Dynarex Corp.

  • K052743 — DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 (December 22, 2005)
  • K052314 — DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE (November 9, 2005)
  • K012957 — TOWEL DRAPE, MODELS 4409, 4410 (March 6, 2002)
  • K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (November 28, 2001)
  • K991694 — DYNAREX DRAIN SPONGE (July 15, 1999)
  • K991695 — DYNAREX NON-WOVEN SPONGE (July 15, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K960388 — DYNAREX NON-WOVEN SPONGE (April 1, 1996)
  • K951660 — DYNAREX GAUZE SPONGE (May 9, 1995)
  • K933308 — DYNAREX GAUZE SPONGE OR PADS (December 22, 1993)

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