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FDA 510(k)

DRYODINE CADEXOMER-IODINE GEL

K-Number: K093320 · 2010-06-18

ApplicantCollegium Pharmaceutical Incorporated
Decision Date2010-06-18
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

DRYODINE CADEXOMER-IODINE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Collegium Pharmaceutical Incorporated. It received FDA 510(k) clearance on 2010-06-18 under 510(k) number K093320. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRYODINE CADEXOMER-IODINE GEL?

DRYODINE CADEXOMER-IODINE GEL is a medical device that received FDA 510(k) clearance on 2010-06-18. The listed applicant is Collegium Pharmaceutical Incorporated. The 510(k) number is K093320.

When did DRYODINE CADEXOMER-IODINE GEL receive FDA 510(k) clearance?

DRYODINE CADEXOMER-IODINE GEL received FDA 510(k) clearance on 2010-06-18, under 510(k) number K093320.

Who is the listed applicant for DRYODINE CADEXOMER-IODINE GEL?

The FDA 510(k) record lists Collegium Pharmaceutical Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRYODINE CADEXOMER-IODINE GEL?

The FDA product code for DRYODINE CADEXOMER-IODINE GEL is FRO. This falls under the Anesthesiology category.

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Other records listing Collegium Pharmaceutical Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093051HYLATOPIC PLUS EMOLLIENT FOAMK083024HYLATOPIC EMOLLIENT FOAM

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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