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FDA 510(k)

FIBER ONE

K-Number: K100746 · 2010-06-11

ApplicantAmerican Medical Systems
Decision Date2010-06-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FIBER ONE is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems. It received FDA 510(k) clearance on 2010-06-11 under 510(k) number K100746. 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 FIBER ONE?

FIBER ONE is a medical device that received FDA 510(k) clearance on 2010-06-11. The listed applicant is American Medical Systems. The 510(k) number is K100746.

When did FIBER ONE receive FDA 510(k) clearance?

FIBER ONE received FDA 510(k) clearance on 2010-06-11, under 510(k) number K100746.

Who is the listed applicant for FIBER ONE?

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

What is the FDA product code for FIBER ONE?

The FDA product code for FIBER ONE 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.

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