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FDA 510(k)

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

K-Number: K230677 · 2023-12-06

ApplicantCork Medical
Decision Date2023-12-06
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) is the device name listed in this FDA 510(k) record. The listed applicant is Cork Medical. It received FDA 510(k) clearance on 2023-12-06 under 510(k) 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. The listed applicant is Cork Medical. The 510(k) number is K230677.

When did Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) receive FDA 510(k) clearance?

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

Who is the listed applicant for Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)?

The FDA 510(k) record lists Cork Medical as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Cork Medical as applicant

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.

K261291Nisus NPWT Canister 500-mL (CPC-500)K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)

Related Devices (Code: OMP)

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.

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, 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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