Product Code: EZZ FDA class 3

Prosthesis, Vas Deferens

Unknown

The Vas Deferens Prosthesis (product code EZZ) is an implantable device designed to reconstruct or replace the vas deferens, the duct that carries sperm from the testes. It is an FDA Class 3 device (highest risk), requiring Premarket Approval (PMA). No regulation number or medical specialty has been formally assigned. This device is designated as an implant and is reviewed by the Gastroenterology and Urology panel.

510(k)s
1
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active

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Basic Information

Product Code
EZZ
Device Class
FDA class 3
Medical Specialty
Unknown
Review Panel
GU
Submission Type
2

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 1 510(k) clearance via K numbers.

K Number Device Name
K851719 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS