FDA 510(k)

coactiv+ Antimicrobial Wound Gel

K-Number: K241809 · 2024-07-19

Decision Date2024-07-19

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

coactiv+ Antimicrobial Wound Gel is a medical device manufactured by Kane Biotech, Inc.. It received FDA 510(k) clearance on 2024-07-19 under approval number K241809. 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 coactiv+ Antimicrobial Wound Gel?

coactiv+ Antimicrobial Wound Gel is a medical device that received FDA 510(k) clearance on 2024-07-19. It is manufactured by Kane Biotech, Inc.. The 510(k) number is K241809.

When was coactiv+ Antimicrobial Wound Gel approved by the FDA?

coactiv+ Antimicrobial Wound Gel received FDA 510(k) clearance on 2024-07-19, under approval number K241809.

What company makes coactiv+ Antimicrobial Wound Gel?

coactiv+ Antimicrobial Wound Gel is manufactured by Kane Biotech, Inc..

What is the FDA product code for coactiv+ Antimicrobial Wound Gel?

The FDA product code for coactiv+ Antimicrobial Wound Gel is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT07604636 Adjunctive Ozone Therapy for Residual Periodontal Pockets COMPLETED NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING NCT07099482 "Ultrasound-Enhanced Propolis Therapy for Healing Diabetic Foot Wounds" NOT_YET_RECRUITING NCT07551297 Ozone Therapy After Open Flap Debridement in Periodontitis COMPLETED NCT07066254 The Mepilex Cesarean Delivery Trial NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025)

Other Devices by Kane Biotech, Inc.

K223259coactiv+ Antimicrobial Wound Gel K252759revyve® Antimicrobial Skin and Wound Cleanser

Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC

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.