FDA 510(k)

Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)

K-Number: K230677 · 2023-12-06

Decision Date2023-12-06

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) is a medical device manufactured by Cork Medical. It received FDA 510(k) clearance on 2023-12-06 under approval number K230677. 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 Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)?

Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) is a medical device that received FDA 510(k) clearance on 2023-12-06. It is manufactured by Cork Medical. The 510(k) number is K230677.

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

Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) received FDA 510(k) clearance on 2023-12-06, under approval number K230677.

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

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

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

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

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Cork Medical

K241061VERSA Negative Pressure Wound Therapy 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.