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FDA 510(k)

Invia® Integrated Dressing

K-Number: K223388 · 2023-07-07

ApplicantMedela AG
Decision Date2023-07-07
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Invia® Integrated Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2023-07-07 under 510(k) number K223388. 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 Invia® Integrated Dressing?

Invia® Integrated Dressing is a medical device that received FDA 510(k) clearance on 2023-07-07. The listed applicant is Medela AG. The 510(k) number is K223388.

When did Invia® Integrated Dressing receive FDA 510(k) clearance?

Invia® Integrated Dressing received FDA 510(k) clearance on 2023-07-07, under 510(k) number K223388.

Who is the listed applicant for Invia® Integrated Dressing?

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

What is the FDA product code for Invia® Integrated Dressing?

The FDA product code for Invia® Integrated Dressing is OMP.

Other records listing Medela AG 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.

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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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