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FDA 510(k)

VERSA Negative Pressure Wound Therapy System (VCMPP-100)

K-Number: K241061 · 2024-08-21

ApplicantCork Medical
Decision Date2024-08-21
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VERSA Negative Pressure Wound Therapy 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 2024-08-21 under 510(k) 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. The listed applicant is Cork Medical. The 510(k) number is K241061.

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

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

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

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

Related Clinical Trials

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.

NCT04042259Delayed Primary Closure Using Negative Pressure Wound TherapyACTIVE_NOT_RECRUITINGNCT04618406The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower LimbCOMPLETEDNCT04955730NPWT in Patients Undergoing Surgical Procedures for Management of GI MalignanciesCOMPLETEDNCT05598398NPWTi on Closure of Chronic Pressure SoresRECRUITINGNCT05615844Antibiotic Cement Bead Pouch Versus Negative Pressure Wound TherapyRECRUITINGNCT05977816PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy WoundsACTIVE_NOT_RECRUITING

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)K230677Cork Medical VERSA Negative Pressure Wound 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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