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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 a medical device manufactured by Kci USA, Inc.. It received FDA 510(k) clearance on 2019-02-15 under approval 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. It is manufactured by Kci USA, Inc.. The 510(k) number is K181507.

When was PREVENA RESTOR(TM) Incision Management System approved by the FDA?

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

What company makes PREVENA RESTOR(TM) Incision Management System?

PREVENA RESTOR(TM) Incision Management System is manufactured by Kci USA, Inc..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 40061911 Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New Medical Device Regulations in Europe. Medical devices (Auckland, N.Z.) (2025)

Other Devices by Kci USA, Inc.

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)

View all 13 devices →

Related Devices (Code: OMP)

K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc. K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power SupplyMedela AG K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC

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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