FDA 510(k) Premarket Notification K172344: Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)

Submission Details & Decision

Normalized public record details for 510(k) notification K172344.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K172344

Applicant / Sponsor

Medax Srl Unipersonale

Device Name

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

Product Code

KNW

Decision Date

2017-11-13

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Traditional

Third Party Flag

Date Received

2017-08-02

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