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FDA 510(k)

ConvaVAC™ Negative Pressure Wound Therapy System

K-Number: K253263 · 2026-06-24

ApplicantConvatec Limited, Gdc Building
Decision Date2026-06-24
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ConvaVAC™ Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited, Gdc Building. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K253263. 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 ConvaVAC™ Negative Pressure Wound Therapy System?

ConvaVAC™ Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Convatec Limited, Gdc Building. The 510(k) number is K253263.

When did ConvaVAC™ Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

ConvaVAC™ Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2026-06-24, under 510(k) number K253263.

Who is the listed applicant for ConvaVAC™ Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Convatec Limited, Gdc Building as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ConvaVAC™ Negative Pressure Wound Therapy System?

The FDA product code for ConvaVAC™ Negative Pressure Wound Therapy System 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.

NCT07342049ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic WoundsRECRUITINGNCT04042259Delayed 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 TherapyRECRUITING

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.

K253199CURASYS 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.K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam AccessoryDeroyal Industries, 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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