FDA 510(k)

Ion Endoluminal System ; Flexision Biopsy Needle

Número K: K182188 · 2019-02-14

Data da decisão2019-02-14

Código do produtoEOQ

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ion Endoluminal System ; Flexision Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Intuitive Surgical. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K182188. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ion Endoluminal System ; Flexision Biopsy Needle?

Ion Endoluminal System ; Flexision Biopsy Needle is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Intuitive Surgical. The 510(k) number is K182188.

When did Ion Endoluminal System ; Flexision Biopsy Needle receive FDA 510(k) clearance?

Ion Endoluminal System ; Flexision Biopsy Needle received FDA 510(k) clearance on 2019-02-14, under 510(k) number K182188.

Who is the listed applicant for Ion Endoluminal System ; Flexision Biopsy Needle?

The FDA 510(k) record lists Intuitive Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ion Endoluminal System ; Flexision Biopsy Needle?

The FDA product code for Ion Endoluminal System ; Flexision Biopsy Needle is EOQ.

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Fonte oficial

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