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FDA 510(k)

Invia Abdominal Dressing Kit

K-Number: K182191 · 2019-02-01

ApplicantMedela AG
Decision Date2019-02-01
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Invia Abdominal Dressing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2019-02-01 under 510(k) number K182191. 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 Abdominal Dressing Kit?

Invia Abdominal Dressing Kit is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Medela AG. The 510(k) number is K182191.

When did Invia Abdominal Dressing Kit receive FDA 510(k) clearance?

Invia Abdominal Dressing Kit received FDA 510(k) clearance on 2019-02-01, under 510(k) number K182191.

Who is the listed applicant for Invia Abdominal Dressing Kit?

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 Abdominal Dressing Kit?

The FDA product code for Invia Abdominal Dressing Kit is OMP.

Other records listing Medela AG as applicant

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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.

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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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