FDA Product Code KHJ: Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Leading manufacturers include Cook Biotech Incorporated.
33
Total
33
Cleared
128d
Avg days
1991
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) Devices (Product Code KHJ)
33 devices
About Product Code KHJ - Regulatory Context
510(k) Submission Activity
33 total 510(k) submissions under product code KHJ since 1991, with 33 receiving FDA clearance (average review time: 128 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
KHJ devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →