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FDA 510(k)

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System

K-Number: K160487 · 2016-12-09

ApplicantKci USA, Inc.
Decision Date2016-12-09
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc.. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K160487. 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 V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System?

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Kci USA, Inc.. The 510(k) number is K160487.

When did V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System receive FDA 510(k) clearance?

V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System received FDA 510(k) clearance on 2016-12-09, under 510(k) number K160487.

Who is the listed applicant for V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System?

The FDA 510(k) record lists Kci USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System?

The FDA product code for V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) 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 MalignanciesCOMPLETEDNCT05615844Antibiotic Cement Bead Pouch Versus Negative Pressure Wound TherapyRECRUITINGNCT05977816PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy WoundsACTIVE_NOT_RECRUITINGNCT06025253PINTA - Prophylactic Incisional Negative Pressure Therapy for Major AmputationsRECRUITING

Other records listing Kci USA, Inc. 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.

K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemK200390V.A.C. DERMATAC DrapeK190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)K181505V.A.C. DERMATAC DrapeK183543ACTIV.A.C. Therapy Unit

View all 12 devices →

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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