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FDA 510(k)

Prevena Plus 125 Therapy Unit

K-Number: K223263 · 2023-02-13

Applicant3M
Decision Date2023-02-13
Product CodeQFC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Prevena Plus 125 Therapy Unit is the device name listed in this FDA 510(k) record. The listed applicant is 3M. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K223263. The device is classified under product code QFC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prevena Plus 125 Therapy Unit?

Prevena Plus 125 Therapy Unit is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is 3M. The 510(k) number is K223263.

When did Prevena Plus 125 Therapy Unit receive FDA 510(k) clearance?

Prevena Plus 125 Therapy Unit received FDA 510(k) clearance on 2023-02-13, under 510(k) number K223263.

Who is the listed applicant for Prevena Plus 125 Therapy Unit?

The FDA 510(k) record lists 3M as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prevena Plus 125 Therapy Unit?

The FDA product code for Prevena Plus 125 Therapy Unit is QFC.

Other records listing 3M 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.

View all 54 devices →

Related Devices (Code: QFC)

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.

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.