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FDA 510(k)

Kendall NPWT Incision Management Dressing Kit

K-Number: K191101 · 2020-07-31

ApplicantCardinalhealth
Decision Date2020-07-31
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Kendall NPWT Incision Management Dressing Kit is a medical device manufactured by Cardinalhealth. It received FDA 510(k) clearance on 2020-07-31 under approval number K191101. 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 Kendall NPWT Incision Management Dressing Kit?

Kendall NPWT Incision Management Dressing Kit is a medical device that received FDA 510(k) clearance on 2020-07-31. It is manufactured by Cardinalhealth. The 510(k) number is K191101.

When was Kendall NPWT Incision Management Dressing Kit approved by the FDA?

Kendall NPWT Incision Management Dressing Kit received FDA 510(k) clearance on 2020-07-31, under approval number K191101.

What company makes Kendall NPWT Incision Management Dressing Kit?

Kendall NPWT Incision Management Dressing Kit is manufactured by Cardinalhealth.

What is the FDA product code for Kendall NPWT Incision Management Dressing Kit?

The FDA product code for Kendall NPWT Incision Management Dressing Kit is OMP.

Related Clinical Trials

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Other Devices by Cardinalhealth

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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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