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FDA 510(k)

MEDELA INVIA WOUND THERAPY

K-Number: K080357 · 2008-07-24

ApplicantMedela AG
Decision Date2008-07-24
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDELA INVIA WOUND THERAPY is the device name listed in this FDA 510(k) record. The listed applicant is Medela AG. It received FDA 510(k) clearance on 2008-07-24 under 510(k) number K080357. 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 MEDELA INVIA WOUND THERAPY?

MEDELA INVIA WOUND THERAPY is a medical device that received FDA 510(k) clearance on 2008-07-24. The listed applicant is Medela AG. The 510(k) number is K080357.

When did MEDELA INVIA WOUND THERAPY receive FDA 510(k) clearance?

MEDELA INVIA WOUND THERAPY received FDA 510(k) clearance on 2008-07-24, under 510(k) number K080357.

Who is the listed applicant for MEDELA INVIA WOUND THERAPY?

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 MEDELA INVIA WOUND THERAPY?

The FDA product code for MEDELA INVIA WOUND THERAPY is OMP.

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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.

K251377Magic InBraK223388Invia® Integrated DressingK214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemK191653Freestyle FlexK182191Invia Abdominal Dressing KitK180415Invia White Foam NPWT

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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.

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.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.

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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