FDA 510(k)

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22

K-Number: K193542 · 2020-10-08

Decision Date2020-10-08

Product CodeKDI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 is a medical device manufactured by Bellco Srl. It received FDA 510(k) clearance on 2020-10-08 under approval number K193542. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22?

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 is a medical device that received FDA 510(k) clearance on 2020-10-08. It is manufactured by Bellco Srl. The 510(k) number is K193542.

When was Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 approved by the FDA?

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 received FDA 510(k) clearance on 2020-10-08, under approval number K193542.

What company makes Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22?

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 is manufactured by Bellco Srl.

What is the FDA product code for Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22?

The FDA product code for Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 is KDI.

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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.