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FDA 510(k)

Atteris Antimicrobial Skin & Wound Cleanser

K-Number: K160192 · 2016-07-28

ApplicantRochal Industries, LLC
Decision Date2016-07-28
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Atteris Antimicrobial Skin & Wound Cleanser is a medical device manufactured by Rochal Industries, LLC. It received FDA 510(k) clearance on 2016-07-28 under approval number K160192. 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 Atteris Antimicrobial Skin & Wound Cleanser?

Atteris Antimicrobial Skin & Wound Cleanser is a medical device that received FDA 510(k) clearance on 2016-07-28. It is manufactured by Rochal Industries, LLC. The 510(k) number is K160192.

When was Atteris Antimicrobial Skin & Wound Cleanser approved by the FDA?

Atteris Antimicrobial Skin & Wound Cleanser received FDA 510(k) clearance on 2016-07-28, under approval number K160192.

What company makes Atteris Antimicrobial Skin & Wound Cleanser?

Atteris Antimicrobial Skin & Wound Cleanser is manufactured by Rochal Industries, LLC.

What is the FDA product code for Atteris Antimicrobial Skin & Wound Cleanser?

The FDA product code for Atteris Antimicrobial Skin & Wound Cleanser 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 Rochal Industries, LLC

K161212Atteris Antimicrobial Skin Protectant K160684Atteris No-Sting Skin Protectant K182733Rochal Bioshield Silicone Film K192527Rochal Antimicrobial Wound Gel

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.

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