Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Oculus Innovative Sciences. It received FDA 510(k) clearance on 2016-04-19 under 510(k) 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. The listed applicant is Oculus Innovative Sciences. The 510(k) number is K153648.

When did Microcyn Plus Skin and Wound Hydrogel receive FDA 510(k) clearance?

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

Who is the listed applicant for Microcyn Plus Skin and Wound Hydrogel?

The FDA 510(k) record lists Oculus Innovative Sciences as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT05411484Investigation of Laser Assisted Drug Delivery of NanoDOX®ACTIVE_NOT_RECRUITINGNCT07453927Blue Light for Donor Site Healing in Burn PatientsRECRUITINGNCT07549737Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound ManagementCOMPLETEDNCT07642973A Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial AbrasionsNOT_YET_RECRUITINGNCT07656818Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural HematomaRECRUITINGNCT07679243A Clinical Study on the Safety and Efficacy of Wide-Band Ultrasound Combined With Traditional Chinese Medicine Preparations in the Prevention and Treatment of KeloidsNOT_YET_RECRUITING

Other records listing Oculus Innovative Sciences 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.

K162217LOYONK161034Microcyn Plus Wound Care Solution

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, 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.

↑