FDA 510(k)

Wolf445nm

K-Number: K192272 · 2020-03-17

Decision Date2020-03-17

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Wolf445nm is a medical device manufactured by A.R.C Laser GmbH. It received FDA 510(k) clearance on 2020-03-17 under approval number K192272. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wolf445nm?

Wolf445nm is a medical device that received FDA 510(k) clearance on 2020-03-17. It is manufactured by A.R.C Laser GmbH. The 510(k) number is K192272.

When was Wolf445nm approved by the FDA?

Wolf445nm received FDA 510(k) clearance on 2020-03-17, under approval number K192272.

What company makes Wolf445nm?

Wolf445nm is manufactured by A.R.C Laser GmbH.

What is the FDA product code for Wolf445nm?

The FDA product code for Wolf445nm is GEX. This falls under the Gastroenterology category.

Other Devices by A.R.C Laser GmbH

K161403A.R.C. Laser Surgical Fibers and Probes K170183Cetus system, Cetus probe K220531FOX 810, FOX 980

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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.