DRYODINE CADEXOMER-IODINE GEL— 510(k) K093320

Name: FDA 510(k) clearance K093320
Creator: U.S. Food and Drug Administration
Published: 2010-06-18

Substantially Equivalent

Collegium Pharmaceutical Incorporated

FDA 510(k) clearance K093320 for DRYODINE CADEXOMER-IODINE GEL, Substantially Equivalent on 2010-06-18. Applicant: Collegium Pharmaceutical Incorporated. Device class: Unclassified.

Clearance details

Applicant: Collegium Pharmaceutical Incorporated
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2009-10-23
Decision date: 2010-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cumberland, RI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRO

view all

K254041 — SkinSmart Antimicrobial HydroGel2026-09-11
K261646 — Redermax® Antibacterial Wound Matrix2026-08-14
K253665 — Vashe Plus Antimicrobial Solution2026-08-11
K251929 — SilverCeuticals® Antimicrobial Wound Gel2026-06-24
K261023 — Microdacyn Wound Irrigation Solution2026-06-24

More clearances from Collegium Pharmaceutical Incorporated

view all

K093051 — HYLATOPIC PLUS EMOLLIENT FOAM2009-12-07
K083024 — HYLATOPIC EMOLLIENT FOAM2009-03-27

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.