FDA 510(k)

SabreLine 和 SabreGuard 激光光纤

K号: K182831 · 2018-12-10

决定日期2018-12-10

产品代码GEX

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决定实质等同

器械摘要

SabreLine and SabreGuard Laser Fibers is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) 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.

常见问题

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. The listed applicant is Coloplast Corp.. The 510(k) number is K182831.

When did SabreLine and SabreGuard Laser Fibers receive FDA 510(k) clearance?

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

Who is the listed applicant for SabreLine and SabreGuard Laser Fibers?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

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.

列明Coloplast Corp.为申报人的其他记录

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