510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KHJClass II

Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

21 CFR 874.3620 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KHJ is the FDA product code for Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material), a class II device type, regulated under 21 CFR 874.3620. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
KHJ
Device name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
34
Ingested recalls
2

Clearances, product code KHJ

By decision year
34 clearances under product code KHJ with a decision year between 1991 and 2026, 1998 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KHJ by decision year
YearClearances
19911
19931
19951
19972
19984
19991
20002
20011
20021
20041
20053
20063
20071
20083
20111
20122
20132
20151
20161
20241
20261

Applicants with the most clearances

Product code KHJ
Applicants holding the most 510(k) clearances under product code KHJ
ApplicantClearances
Ceremed, Inc.8
Xomed, Inc.5
Cook Biotech Incorporated2
Cook Biotech Incorprated2
Curamedical, BV2
Exmoor Plastics Limited2
Bioform, Inc.1
Bioplexus Corp.1
Cambridgemed1
Doctor'S Research Group, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order