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FDA 510(k)

Lumfuse TP

K-Number: K173189 · 2018-06-08

ApplicantPrecifit Medical, Ltd.
Decision Date2018-06-08
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Lumfuse TP is the device name listed in this FDA 510(k) record. The listed applicant is Precifit Medical, Ltd.. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K173189. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lumfuse TP?

Lumfuse TP is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is Precifit Medical, Ltd.. The 510(k) number is K173189.

When did Lumfuse TP receive FDA 510(k) clearance?

Lumfuse TP received FDA 510(k) clearance on 2018-06-08, under 510(k) number K173189.

Who is the listed applicant for Lumfuse TP?

The FDA 510(k) record lists Precifit Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lumfuse TP?

The FDA product code for Lumfuse TP is MAX.

Other records listing Precifit Medical, Ltd. 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.

K172568CervageK171630LumFuse-TPK163327Precifit Medical Kirschner Wires

Related Devices (Code: MAX)

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.

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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.

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