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FDA 510(k)

3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)

K-Number: K241134 · 2024-05-23

ApplicantKci USA, Inc.
Decision Date2024-05-23
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc.. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K241134. 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 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)?

3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Kci USA, Inc.. The 510(k) number is K241134.

When did 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) receive FDA 510(k) clearance?

3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) received FDA 510(k) clearance on 2024-05-23, under 510(k) number K241134.

Who is the listed applicant for 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)?

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

What is the FDA product code for 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)?

The FDA product code for 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) is OMP.

Other records listing Kci USA, Inc. 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.

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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