FDA 510(k)

A.R.C. Laser Surgical Fibers and Probes

K-Number: K161403 · 2016-08-16

Decision Date2016-08-16

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

A.R.C. Laser Surgical Fibers and Probes is a medical device manufactured by A.R.C Laser GmbH. It received FDA 510(k) clearance on 2016-08-16 under approval number K161403. 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 A.R.C. Laser Surgical Fibers and Probes?

A.R.C. Laser Surgical Fibers and Probes is a medical device that received FDA 510(k) clearance on 2016-08-16. It is manufactured by A.R.C Laser GmbH. The 510(k) number is K161403.

When was A.R.C. Laser Surgical Fibers and Probes approved by the FDA?

A.R.C. Laser Surgical Fibers and Probes received FDA 510(k) clearance on 2016-08-16, under approval number K161403.

What company makes A.R.C. Laser Surgical Fibers and Probes?

A.R.C. Laser Surgical Fibers and Probes is manufactured by A.R.C Laser GmbH.

What is the FDA product code for A.R.C. Laser Surgical Fibers and Probes?

The FDA product code for A.R.C. Laser Surgical Fibers and Probes is GEX. This falls under the Gastroenterology category.

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Other Devices by A.R.C Laser GmbH

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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.