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 | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K851719 | 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS | Jul 02, 1985 | Substantially Equivalent | Artiberia |