FDA Product Code HPZ: Implant, Eye Sphere
Leading manufacturers include Fci (France Chirurgie Instrumentation) Sas, Storz Instrument Co. and W.L. Gore & Associates, Inc..
39
Total
39
Cleared
126d
Avg days
1978
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Implant, Eye Sphere Devices (Product Code HPZ)
39 devices
Cleared
Jun 24, 2022
EZYPOR
Fci (France Chirurgie Instrumentation) Sas
Ophthalmic
298d
Cleared
Aug 22, 1996
GORE SPHEREX IMPLANT
W.L. Gore & Associates, Inc.
Ophthalmic
72d
Cleared
Mar 30, 1992
STERILE/SINGLE USE EYE SPHERE IMPLANTS
Storz Instrument Co.
Ophthalmic
21d
About Product Code HPZ - Regulatory Context
510(k) Submission Activity
39 total 510(k) submissions under product code HPZ since 1978, with 39 receiving FDA clearance (average review time: 126 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.