FDA 510(k)

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver

Numéro K : K230015 · 2023-06-16

Date de décision2023-06-16

Code produitKNW

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver is the device name listed in this FDA 510(k) record. The listed applicant is Laurane Medical Sas. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K230015. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver?

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Laurane Medical Sas. The 510(k) number is K230015.

When did OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver receive FDA 510(k) clearance?

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver received FDA 510(k) clearance on 2023-06-16, under 510(k) number K230015.

Who is the listed applicant for OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver?

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

What is the FDA product code for OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver?

The FDA product code for OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver is KNW.

Essais cliniques associés

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Dispositifs connexes (Code : KNW)

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Source officielle

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