FDA 510(k)

Hydrocleanse Antimicrobial Skin and Wound Care Solution

K-Number: K171727 · 2017-07-26

Decision Date2017-07-26

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

Hydrocleanse Antimicrobial Skin and Wound Care Solution is a medical device manufactured by Sonoma Pharmaceuticals. It received FDA 510(k) clearance on 2017-07-26 under approval number K171727. 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 Hydrocleanse Antimicrobial Skin and Wound Care Solution?

Hydrocleanse Antimicrobial Skin and Wound Care Solution is a medical device that received FDA 510(k) clearance on 2017-07-26. It is manufactured by Sonoma Pharmaceuticals. The 510(k) number is K171727.

When was Hydrocleanse Antimicrobial Skin and Wound Care Solution approved by the FDA?

Hydrocleanse Antimicrobial Skin and Wound Care Solution received FDA 510(k) clearance on 2017-07-26, under approval number K171727.

What company makes Hydrocleanse Antimicrobial Skin and Wound Care Solution?

Hydrocleanse Antimicrobial Skin and Wound Care Solution is manufactured by Sonoma Pharmaceuticals.

What is the FDA product code for Hydrocleanse Antimicrobial Skin and Wound Care Solution?

The FDA product code for Hydrocleanse Antimicrobial Skin and Wound Care Solution 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 NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) 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 Sonoma Pharmaceuticals

K172622Microcyn 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

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