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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 a medical device manufactured by Vomaris Wound Care, Inc.. It received FDA 510(k) clearance on 2018-12-10 under approval 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. It is manufactured by Vomaris Wound Care, Inc.. The 510(k) number is K180533.

When was Procellera Composite Antibacterial Wound Dressing approved by the FDA?

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

What company makes Procellera Composite Antibacterial Wound Dressing?

Procellera Composite Antibacterial Wound Dressing is manufactured by Vomaris Wound Care, Inc..

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

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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) PMID: 40574448 [Research and Discussion on the Whole Lifecycle Supervision of Typical Class Ⅱ Wound Dressing Products]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

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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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