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FDA 510(k)

Kendall NPWT Incision Management Dressing Kit

K-Number: K191101 · 2020-07-31

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

Device Summary

Kendall NPWT Incision Management Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2020-07-31 under 510(k) 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. The listed applicant is Cardinalhealth. The 510(k) number is K191101.

When did Kendall NPWT Incision Management Dressing Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Kendall NPWT Incision Management Dressing Kit?

The FDA 510(k) record lists Cardinalhealth as the applicant. This does not by itself establish the device manufacturer.

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

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.

Other records listing Cardinalhealth 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.

View all 11 devices →

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.

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.