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FDA 510(k)

PREVENA RESTOR(TM) Incision Management System

K-Number: K181507 · 2019-02-15

ApplicantKci USA, Inc.
Decision Date2019-02-15
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PREVENA RESTOR(TM) Incision Management 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 2019-02-15 under 510(k) number K181507. 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 PREVENA RESTOR(TM) Incision Management System?

PREVENA RESTOR(TM) Incision Management System is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Kci USA, Inc.. The 510(k) number is K181507.

When did PREVENA RESTOR(TM) Incision Management System receive FDA 510(k) clearance?

PREVENA RESTOR(TM) Incision Management System received FDA 510(k) clearance on 2019-02-15, under 510(k) number K181507.

Who is the listed applicant for PREVENA RESTOR(TM) Incision Management 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 PREVENA RESTOR(TM) Incision Management System?

The FDA product code for PREVENA RESTOR(TM) Incision Management System is OMP.

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

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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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