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FDA 510(k)

extriCARE 1000 Negative Pressure Wound Therapy System

K-Number: K213906 · 2023-03-08

ApplicantAlleva Medical, Ltd.
Decision Date2023-03-08
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

extriCARE 1000 Negative Pressure Wound Therapy System is a medical device manufactured by Alleva Medical, Ltd.. It received FDA 510(k) clearance on 2023-03-08 under approval number K213906. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the extriCARE 1000 Negative Pressure Wound Therapy System?

extriCARE 1000 Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2023-03-08. It is manufactured by Alleva Medical, Ltd.. The 510(k) number is K213906.

When was extriCARE 1000 Negative Pressure Wound Therapy System approved by the FDA?

extriCARE 1000 Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2023-03-08, under approval number K213906.

What company makes extriCARE 1000 Negative Pressure Wound Therapy System?

extriCARE 1000 Negative Pressure Wound Therapy System is manufactured by Alleva Medical, Ltd..

What is the FDA product code for extriCARE 1000 Negative Pressure Wound Therapy System?

The FDA product code for extriCARE 1000 Negative Pressure Wound Therapy System is OMP.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40775863 Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship. Studies in health technology and informatics (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, 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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