FDA 510(k)

LumFuse-TP

K-Number: K171630 · 2017-07-25

Decision Date2017-07-25

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 2017-07-25 under 510(k) number K171630. 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 2017-07-25. The listed applicant is Precifit Medical, Ltd.. The 510(k) number is K171630.

When did LumFuse-TP receive FDA 510(k) clearance?

LumFuse-TP received FDA 510(k) clearance on 2017-07-25, under 510(k) number K171630.

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.

K173189Lumfuse TP K172568Cervage K163327Precifit Medical Kirschner Wires

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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.