FDA 510(k)

Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)

K-Number: K243187 · 2025-06-27

Decision Date2025-06-27

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Nisus ONE Negative Pressure Wound Therapy System (OCMPP-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 2025-06-27 under 510(k) number K243187. 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 Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)?

Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Cork Medical. The 510(k) number is K243187.

When did Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) receive FDA 510(k) clearance?

Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243187.

Who is the listed applicant for Nisus ONE Negative Pressure Wound Therapy System (OCMPP-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 Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)?

The FDA product code for Nisus ONE Negative Pressure Wound Therapy System (OCMPP-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.

NCT04618406The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower LimbCOMPLETED NCT06259409Regenn® Therapy System Safety StudyACTIVE_NOT_RECRUITING NCT07607366Effects of Negative Pressure Wound Bandaging After MastectomyRECRUITING NCT07770633Negative Pressure Wound Therapy Devices in Total Knee ArthroplastyNOT_YET_RECRUITING NCT04042259Delayed Primary Closure Using Negative Pressure Wound TherapyACTIVE_NOT_RECRUITING NCT04955730NPWT in Patients Undergoing Surgical Procedures for Management of GI MalignanciesCOMPLETED

Other records listing Cork Medical as applicant

K261291Nisus NPWT Canister 500-mL (CPC-500)K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)

Related Devices (Code: OMP)

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

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.