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FDA 510(k)

Procellera Composite Antibacterial Wound Dressing

K-Number: K180533 · 2018-12-10

ApplicantVomaris Wound Care, Inc.
Decision Date2018-12-10
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Procellera Composite Antibacterial Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Vomaris Wound Care, Inc.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K180533. 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 Procellera Composite Antibacterial Wound Dressing?

Procellera Composite Antibacterial Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Vomaris Wound Care, Inc.. The 510(k) number is K180533.

When did Procellera Composite Antibacterial Wound Dressing receive FDA 510(k) clearance?

Procellera Composite Antibacterial Wound Dressing received FDA 510(k) clearance on 2018-12-10, under 510(k) number K180533.

Who is the listed applicant for Procellera Composite Antibacterial Wound Dressing?

The FDA 510(k) record lists Vomaris Wound Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Procellera Composite Antibacterial Wound Dressing?

The FDA product code for Procellera Composite Antibacterial Wound Dressing 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.

NCT06337292Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk FracturesRECRUITINGNCT07758855Nanotechnological Silver-Coated Dressing in Diabetic Foot UlcersCOMPLETED

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.

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