FDA 510(k)

Strome-Blitzer Cytology Balloon

K-Number: K182159 · 2019-06-13

Decision Date2019-06-13

Product CodeEOX

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Strome-Blitzer Cytology Balloon is a medical device manufactured by Adn International, LLC. It received FDA 510(k) clearance on 2019-06-13 under approval number K182159. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Strome-Blitzer Cytology Balloon?

Strome-Blitzer Cytology Balloon is a medical device that received FDA 510(k) clearance on 2019-06-13. It is manufactured by Adn International, LLC. The 510(k) number is K182159.

When was Strome-Blitzer Cytology Balloon approved by the FDA?

Strome-Blitzer Cytology Balloon received FDA 510(k) clearance on 2019-06-13, under approval number K182159.

What company makes Strome-Blitzer Cytology Balloon?

Strome-Blitzer Cytology Balloon is manufactured by Adn International, LLC.

What is the FDA product code for Strome-Blitzer Cytology Balloon?

The FDA product code for Strome-Blitzer Cytology Balloon is EOX.

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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.