FDA 510(k)

MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS

K-Number: K010804 · 2001-10-04

Decision Date2001-10-04

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec, Inc.. It received FDA 510(k) clearance on 2001-10-04 under 510(k) number K010804. 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 MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS?

MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS is a medical device that received FDA 510(k) clearance on 2001-10-04. The listed applicant is Biolitec, Inc.. The 510(k) number is K010804.

When did MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS receive FDA 510(k) clearance?

MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS received FDA 510(k) clearance on 2001-10-04, under 510(k) number K010804.

Who is the listed applicant for MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS?

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

What is the FDA product code for MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS?

The FDA product code for MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS is GEX. This falls under the Gastroenterology category.

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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.