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FDA 510(k)

Bio Fluff System

K-Number: K201861 · 2022-03-02

ApplicantGnali Bocia S.R.L.
Decision Date2022-03-02
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Bio Fluff System is a medical device manufactured by Gnali Bocia S.R.L.. It received FDA 510(k) clearance on 2022-03-02 under approval number K201861. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bio Fluff System?

Bio Fluff System is a medical device that received FDA 510(k) clearance on 2022-03-02. It is manufactured by Gnali Bocia S.R.L.. The 510(k) number is K201861.

When was Bio Fluff System approved by the FDA?

Bio Fluff System received FDA 510(k) clearance on 2022-03-02, under approval number K201861.

What company makes Bio Fluff System?

Bio Fluff System is manufactured by Gnali Bocia S.R.L..

What is the FDA product code for Bio Fluff System?

The FDA product code for Bio Fluff System is KPL.

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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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