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FDA 510(k)

Permadyne

K-Number: K220257 · 2022-02-01

Decision Date2022-02-01
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Permadyne is the device name listed in this FDA 510(k) record. The listed applicant is 3M Deutschland GmbH. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K220257. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Permadyne?

Permadyne is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is 3M Deutschland GmbH. The 510(k) number is K220257.

When did Permadyne receive FDA 510(k) clearance?

Permadyne received FDA 510(k) clearance on 2022-02-01, under 510(k) number K220257.

Who is the listed applicant for Permadyne?

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

What is the FDA product code for Permadyne?

The FDA product code for Permadyne is ELW.

Other records listing 3M Deutschland GmbH 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 7 devices →

Related Devices (Code: ELW)

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.