FDA 510(k)

Fibercure

K-Number: K232076 · 2023-11-02

Decision Date2023-11-02

Product CodeQNF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Fibercure is the device name listed in this FDA 510(k) record. The listed applicant is Lumendo AG. It received FDA 510(k) clearance on 2023-11-02 under 510(k) number K232076. The device is classified under product code QNF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fibercure?

Fibercure is a medical device that received FDA 510(k) clearance on 2023-11-02. The listed applicant is Lumendo AG. The 510(k) number is K232076.

When did Fibercure receive FDA 510(k) clearance?

Fibercure received FDA 510(k) clearance on 2023-11-02, under 510(k) number K232076.

Who is the listed applicant for Fibercure?

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

What is the FDA product code for Fibercure?

The FDA product code for Fibercure is QNF.

Other records listing Lumendo 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.

K231387Endofill

Related Devices (Code: QNF)

K201904Monet Curing LaserCAO Group, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.