FDA 510(k)

Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)

K-Number: K172344 · 2017-11-13

Decision Date2017-11-13

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) is the device name listed in this FDA 510(k) record. The listed applicant is Medax Srl Unipersonale. It received FDA 510(k) clearance on 2017-11-13 under 510(k) number K172344. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)?

Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) is a medical device that received FDA 510(k) clearance on 2017-11-13. The listed applicant is Medax Srl Unipersonale. The 510(k) number is K172344.

When did Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) receive FDA 510(k) clearance?

Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) received FDA 510(k) clearance on 2017-11-13, under 510(k) number K172344.

Who is the listed applicant for Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)?

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

What is the FDA product code for Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)?

The FDA product code for Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) is KNW.

Other records listing Medax Srl Unipersonale as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192101Medone Ultra, Medextra K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System K181803Medax Biopsy Systems III

Related Devices (Code: KNW)

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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.