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FDA 510(k)

Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)

K-Number: K243445 · 2024-12-30

ApplicantBios S.R.L.
Decision Date2024-12-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) is a medical device manufactured by Bios S.R.L.. It received FDA 510(k) clearance on 2024-12-30 under approval number K243445. 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 Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)?

Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) is a medical device that received FDA 510(k) clearance on 2024-12-30. It is manufactured by Bios S.R.L.. The 510(k) number is K243445.

When was Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) approved by the FDA?

Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) received FDA 510(k) clearance on 2024-12-30, under approval number K243445.

What company makes Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)?

Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) is manufactured by Bios S.R.L..

What is the FDA product code for Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)?

The FDA product code for Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) 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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