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FDA 510(k)

extriCARE® 3000 Negative Wound Pressure Therapy System

K-Number: K221223 · 2023-02-09

ApplicantAlleva Medical Devices
Decision Date2023-02-09
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

extriCARE® 3000 Negative Wound Pressure Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Alleva Medical Devices. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K221223. 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 extriCARE® 3000 Negative Wound Pressure Therapy System?

extriCARE® 3000 Negative Wound Pressure Therapy System is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Alleva Medical Devices. The 510(k) number is K221223.

When did extriCARE® 3000 Negative Wound Pressure Therapy System receive FDA 510(k) clearance?

extriCARE® 3000 Negative Wound Pressure Therapy System received FDA 510(k) clearance on 2023-02-09, under 510(k) number K221223.

Who is the listed applicant for extriCARE® 3000 Negative Wound Pressure Therapy System?

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

What is the FDA product code for extriCARE® 3000 Negative Wound Pressure Therapy System?

The FDA product code for extriCARE® 3000 Negative Wound Pressure 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.

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 Alleva Medical Devices 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.

K251646extriCARE® 1000 Negative Pressure Wound Therapy System

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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