KHJ · Class II · 21 CFR 874.3620

FDA Product Code KHJ: Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)

Leading manufacturers include Ceremed , Inc., Xomed, Inc. and Curamedical, BV.

34
Total
34
Cleared
131d
Avg days
1991
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 202d recently vs 128d historically

FDA 510(k) Cleared Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) Devices (Product Code KHJ)

34 devices
1–24 of 34
Cleared Aug 18, 2026
Tympendi™ (810)
K260266
Grace Medical, Inc.
Ear, Nose, Throat · 202d
Cleared May 24, 2024
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6)
K232646
Cook Biotech Incorporated
Ear, Nose, Throat · 268d
Cleared May 11, 2016
Biodesign Otologic Repair Graft
K161000
Cook Biotech Incorporated
Ear, Nose, Throat · 30d
Cleared Sep 16, 2015
Biodesign Otologic Repair Graft
K150594
Cook Biotech Incorprated
Ear, Nose, Throat · 191d
Cleared Sep 12, 2013
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
K132198
Ceremed , Inc.
Ear, Nose, Throat · 58d
Cleared Feb 27, 2013
BIODESIGN ENT REPAIR GRAFT
K121360
Cook Biotech Incorprated
Ear, Nose, Throat · 296d
Cleared Nov 27, 2012
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
K122561
Ceremed , Inc.
Ear, Nose, Throat · 97d
Cleared Jun 06, 2012
ADAPTAIN SOLUBLE IMPLANT MATERIAL
K120220
Ceremed , Inc.
Ear, Nose, Throat · 133d
Cleared Jan 05, 2011
CERETENE SOLUBLE IMPLANT MATERIAL
K103047
Ceremed , Inc.
Ear, Nose, Throat · 82d
Cleared Dec 09, 2008
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
K080022
Vascular Solutions, Inc.
Ear, Nose, Throat · 341d
Cleared Sep 18, 2008
AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV
K082245
Ceremed , Inc.
Ear, Nose, Throat · 42d
Cleared Jul 18, 2008
AOC SOLUBLE IMPLANT MATERIAL
K081531
Ceremed , Inc.
Ear, Nose, Throat · 46d
Cleared Jan 24, 2007
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE
K070093
Ceremed , Inc.
Ear, Nose, Throat · 14d
Cleared Dec 11, 2006
OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE
K062280
Ceremed , Inc.
Ear, Nose, Throat · 126d
Cleared May 30, 2006
CLEARADEX GEL
K060561
Cambridgemed
Ear, Nose, Throat · 88d
Cleared Apr 13, 2006
GELITA-SPON ABSORBABLE GELATIN SPONGE, USP
K060878
Curamedical, BV
Ear, Nose, Throat · 13d
Cleared Dec 22, 2005
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
K051487
Doctor'S Research Group, Inc.
Ear, Nose, Throat · 199d
Cleared Dec 06, 2005
GELITA-SPON
K051911
Curamedical, BV
Ear, Nose, Throat · 145d
Cleared Jul 11, 2005
SEPRAGEL ENT BIORESORBABLE PACKING/STENT
K043035
Genzyme Corporation
Ear, Nose, Throat · 250d
Cleared Jan 09, 2002
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
K013243
Bioform, Inc.
Ear, Nose, Throat · 103d
Cleared Jul 03, 2001
HYALOMATRIX CO
K003855
Fidia Advanced Biopolymers Srl
Ear, Nose, Throat · 202d
Cleared Dec 15, 2000
MEROGEL CONTROL GEL ENT SURGICAL DRESSING
K002972
Medtronic Xomed
Ear, Nose, Throat · 84d
Cleared Jun 03, 2000
MEROGEL OTOLOGIC PACK
K001148
Xomed, Inc.
Ear, Nose, Throat · 54d
Cleared May 18, 1999
TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
K991324
Heinz Kurz
Ear, Nose, Throat · 29d

About Product Code KHJ - Regulatory Context

510(k) Submission Activity

34 total 510(k) submissions under product code KHJ since 1991, with 34 receiving FDA clearance (average review time: 131 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - KHJ Product Code

Recent submissions under KHJ have taken an average of 202 days to reach a decision - up from 128 days historically. Manufacturers should account for longer review timelines in current project planning.

KHJ devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →