FDA 510(k)

SabreLine and SabreGuard Laser Fibers

K-Number: K182831 · 2018-12-10

Decision Date2018-12-10

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SabreLine and SabreGuard Laser Fibers is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2018-12-10 under approval number K182831. 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 SabreLine and SabreGuard Laser Fibers?

SabreLine and SabreGuard Laser Fibers is a medical device that received FDA 510(k) clearance on 2018-12-10. It is manufactured by Coloplast Corp.. The 510(k) number is K182831.

When was SabreLine and SabreGuard Laser Fibers approved by the FDA?

SabreLine and SabreGuard Laser Fibers received FDA 510(k) clearance on 2018-12-10, under approval number K182831.

What company makes SabreLine and SabreGuard Laser Fibers?

SabreLine and SabreGuard Laser Fibers is manufactured by Coloplast Corp..

What is the FDA product code for SabreLine and SabreGuard Laser Fibers?

The FDA product code for SabreLine and SabreGuard Laser Fibers is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

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