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FDA 510(k)

Microcyn Plus Skin and Wound Hydrogel

K-Number: K153648 · 2016-04-19

ApplicantOculus Innovative Sciences
Decision Date2016-04-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Microcyn Plus Skin and Wound Hydrogel is a medical device manufactured by Oculus Innovative Sciences. It received FDA 510(k) clearance on 2016-04-19 under approval number K153648. 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 Microcyn Plus Skin and Wound Hydrogel?

Microcyn Plus Skin and Wound Hydrogel is a medical device that received FDA 510(k) clearance on 2016-04-19. It is manufactured by Oculus Innovative Sciences. The 510(k) number is K153648.

When was Microcyn Plus Skin and Wound Hydrogel approved by the FDA?

Microcyn Plus Skin and Wound Hydrogel received FDA 510(k) clearance on 2016-04-19, under approval number K153648.

What company makes Microcyn Plus Skin and Wound Hydrogel?

Microcyn Plus Skin and Wound Hydrogel is manufactured by Oculus Innovative Sciences.

What is the FDA product code for Microcyn Plus Skin and Wound Hydrogel?

The FDA product code for Microcyn Plus Skin and Wound Hydrogel is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT06326203 Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia NOT_YET_RECRUITING NCT06914596 A Clinical Trial Comparing 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP to a Control Group Post-SRP. RECRUITING NCT07541196 PAW-Hydrogel for Chronic Wound Healing RECRUITING

Related PubMed Literature

PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Other Devices by Oculus Innovative Sciences

K161034Microcyn Plus Wound Care Solution K162217LOYON

Related Devices (Code: FRO)

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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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