Home / 510(k) Clearances / K093320

510(k) K093320

DRYODINE CADEXOMER-IODINE GEL by Collegium Pharmaceutical Incorporated — Product Code FRO

K093320 is an FDA 510(k) premarket notification submitted by Collegium Pharmaceutical Incorporated for the device "DRYODINE CADEXOMER-IODINE GEL". The FDA issued a decision of Substantially Equivalent on June 18, 2010. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Collegium Pharmaceutical Incorporated has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2010
Date Received
October 23, 2009
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 Collegium Pharmaceutical Incorporated

  • K093051 — HYLATOPIC PLUS EMOLLIENT FOAM (December 7, 2009)
  • K083024 — HYLATOPIC EMOLLIENT FOAM (March 27, 2009)

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