FDA 510(k)

VERSA Negative Pressure Wound Therapy System (VCMPP-100)

K-Number: K241061 · 2024-08-21

Decision Date2024-08-21

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VERSA Negative Pressure Wound Therapy System (VCMPP-100) is a medical device manufactured by Cork Medical. It received FDA 510(k) clearance on 2024-08-21 under approval number K241061. 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 VERSA Negative Pressure Wound Therapy System (VCMPP-100)?

VERSA Negative Pressure Wound Therapy System (VCMPP-100) is a medical device that received FDA 510(k) clearance on 2024-08-21. It is manufactured by Cork Medical. The 510(k) number is K241061.

When was VERSA Negative Pressure Wound Therapy System (VCMPP-100) approved by the FDA?

VERSA Negative Pressure Wound Therapy System (VCMPP-100) received FDA 510(k) clearance on 2024-08-21, under approval number K241061.

What company makes VERSA Negative Pressure Wound Therapy System (VCMPP-100)?

VERSA Negative Pressure Wound Therapy System (VCMPP-100) is manufactured by Cork Medical.

What is the FDA product code for VERSA Negative Pressure Wound Therapy System (VCMPP-100)?

The FDA product code for VERSA Negative Pressure Wound Therapy System (VCMPP-100) is OMP.

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by Cork Medical

K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.