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FDA 510(k)

BIOSYAG 50 MED

K-Number: K043521 · 2005-03-24

ApplicantBios S.R.L.
Decision Date2005-03-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOSYAG 50 MED is the device name listed in this FDA 510(k) record. The listed applicant is Bios S.R.L.. It received FDA 510(k) clearance on 2005-03-24 under 510(k) number K043521. 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 BIOSYAG 50 MED?

BIOSYAG 50 MED is a medical device that received FDA 510(k) clearance on 2005-03-24. The listed applicant is Bios S.R.L.. The 510(k) number is K043521.

When did BIOSYAG 50 MED receive FDA 510(k) clearance?

BIOSYAG 50 MED received FDA 510(k) clearance on 2005-03-24, under 510(k) number K043521.

Who is the listed applicant for BIOSYAG 50 MED?

The FDA 510(k) record lists Bios S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSYAG 50 MED?

The FDA product code for BIOSYAG 50 MED 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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