FDA 510(k)

Kendall NPWT Incision Management Device

K-Number: K202217 · 2021-06-04

Decision Date2021-06-04

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Kendall NPWT Incision Management Device is a medical device manufactured by Cardinalhealth. It received FDA 510(k) clearance on 2021-06-04 under approval number K202217. 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 Device?

Kendall NPWT Incision Management Device is a medical device that received FDA 510(k) clearance on 2021-06-04. It is manufactured by Cardinalhealth. The 510(k) number is K202217.

When was Kendall NPWT Incision Management Device approved by the FDA?

Kendall NPWT Incision Management Device received FDA 510(k) clearance on 2021-06-04, under approval number K202217.

What company makes Kendall NPWT Incision Management Device?

Kendall NPWT Incision Management Device is manufactured by Cardinalhealth.

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

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

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Related PubMed Literature

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Other Devices by Cardinalhealth

K171499Occlusion Detection Dressing Kit K161418Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set K190923Salem Sump Dual Lumen Stomach Tube with ENFit Connection K191101Kendall NPWT Incision Management Dressing Kit K213174Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection K230569Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )

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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.