FDA 510(k)

V.A.C.ULTA Negative Pressure Wound Therapy System

K-Number: K162790 · 2017-01-26

ApplicantKci USA, Inc. (Kinetic Concepts, Inc.)

Decision Date2017-01-26

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

V.A.C.ULTA Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K162790. 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.ULTA Negative Pressure Wound Therapy System?

V.A.C.ULTA Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Kci USA, Inc. (Kinetic Concepts, Inc.). The 510(k) number is K162790.

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

V.A.C.ULTA Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2017-01-26, under 510(k) number K162790.

Who is the listed applicant for V.A.C.ULTA Negative Pressure Wound Therapy System?

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

What is the FDA product code for V.A.C.ULTA Negative Pressure Wound Therapy System?

The FDA product code for V.A.C.ULTA 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.

NCT04042259Delayed Primary Closure Using Negative Pressure Wound TherapyACTIVE_NOT_RECRUITING NCT04618406The Effect of Negative Pressure Wound Therapy on Wound Healing in Major Amputations of the Lower LimbCOMPLETED NCT04955730NPWT in Patients Undergoing Surgical Procedures for Management of GI MalignanciesCOMPLETED NCT05598398NPWTi on Closure of Chronic Pressure SoresRECRUITING NCT05615844Antibiotic Cement Bead Pouch Versus Negative Pressure Wound TherapyRECRUITING NCT05977816PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy WoundsACTIVE_NOT_RECRUITING

Other records listing Kci USA, Inc. (Kinetic Concepts, Inc.) as applicant

K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...

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.