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FDA 510(k)

Kendall NPWT Incision Management Device

K-Number: K202217 · 2021-06-04

ApplicantCardinalhealth
Decision Date2021-06-04
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Kendall NPWT Incision Management Device is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2021-06-04 under 510(k) 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. The listed applicant is Cardinalhealth. The 510(k) number is K202217.

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

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

Who is the listed applicant for Kendall NPWT Incision Management Device?

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 Device?

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

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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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