Product Code: KHJ FDA class 2 21 CFR 874.3620

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

Ear, Nose, Throat

ENT Synthetic Polyamide Polymer (Mesh or Foil Material) is an implantable material used in ear, nose, and throat surgery, fabricated from synthetic polyamide polymer in mesh or foil form, to reconstruct or reinforce structural defects in the head and neck region, including tympanic membrane repair or middle ear reconstruction. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHJ, regulated under 21 CFR 874.3620, within the Ear, Nose, Throat medical specialty. This device is an implant.

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Basic Information

Product Code: KHJ
Device Class: FDA class 2
Regulation Number: 874.3620
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K232646	Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)	May 24, 2024	Substantially Equivalent	Cook Biotech Incorporated
K161000	Biodesign Otologic Repair Graft	May 11, 2016	Substantially Equivalent	Cook Biotech Incorporated
K150594	Biodesign Otologic Repair Graft	Sep 16, 2015	Substantially Equivalent	Cook Biotech Incorprated
K132198	ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI	Sep 12, 2013	Substantially Equivalent	Ceremed , Inc.
K121360	BIODESIGN ENT REPAIR GRAFT	Feb 27, 2013	Substantially Equivalent	Cook Biotech Incorprated
K122561	ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN	Nov 27, 2012	Substantially Equivalent	Ceremed , Inc.
K120220	ADAPTAIN SOLUBLE IMPLANT MATERIAL	Jun 06, 2012	Substantially Equivalent	Ceremed , Inc.
K103047	CERETENE SOLUBLE IMPLANT MATERIAL	Jan 05, 2011	Substantially Equivalent	Ceremed , Inc.
K080022	GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP	Dec 09, 2008	Substantially Equivalent	Vascular Solutions, Inc.
K082245	AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV	Sep 18, 2008	Substantially Equivalent	Ceremed , Inc.
K081531	AOC SOLUBLE IMPLANT MATERIAL	Jul 18, 2008	Substantially Equivalent	Ceremed , Inc.
K070093	OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE	Jan 24, 2007	Substantially Equivalent	Ceremed , Inc.
K062280	OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE	Dec 11, 2006	Substantially Equivalent	Ceremed , Inc.
K060561	CLEARADEX GEL	May 30, 2006	Substantially Equivalent	Cambridgemed
K060878	GELITA-SPON ABSORBABLE GELATIN SPONGE, USP	Apr 13, 2006	Substantially Equivalent	Curamedical, BV
K051487	DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE	Dec 22, 2005	Substantially Equivalent	Doctor'S Research Group, Inc.
K051911	GELITA-SPON	Dec 06, 2005	Substantially Equivalent	Curamedical, BV
K043035	SEPRAGEL ENT BIORESORBABLE PACKING/STENT	Jul 11, 2005	Substantially Equivalent	Genzyme Corporation
K033796	KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS	Jan 30, 2004	Substantially Equivalent	Heinz Kurz GmbH Medizintechnik
K013243	COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1	Jan 09, 2002	Substantially Equivalent	Bioform, Inc.
K003855	HYALOMATRIX CO	Jul 03, 2001	Substantially Equivalent	Fidia Advanced Biopolymers Srl
K002972	MEROGEL CONTROL GEL ENT SURGICAL DRESSING	Dec 15, 2000	Substantially Equivalent	Medtronic Xomed
K001148	MEROGEL OTOLOGIC PACK	Jun 03, 2000	Substantially Equivalent	Xomed, Inc.
K991324	TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)	May 18, 1999	Substantially Equivalent	Heinz Kurz
K982870	EPIFILM OTOLOGIC LAMINA	Nov 03, 1998	Substantially Equivalent	Xomed, Inc.
K982294	XOMED SILICONE PRE-FORM BLOCKS	Sep 18, 1998	Substantially Equivalent	Xomed, Inc.
K972700	EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)	Jul 16, 1998	Substantially Equivalent	Exmoor Plastics , Ltd.
K974311	VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT	Mar 04, 1998	Substantially Equivalent	Gyrus Ent LLC
K970910	XOMED SILICONE BLOCK/STRIP	May 02, 1997	Substantially Equivalent	Xomed, Inc.
K964484	KARTUSH TM PATCHER	Jan 24, 1997	Substantially Equivalent	Xomed, Inc.
K953013	MEROCEL REINFORCED SILICONE SHEETS	Aug 29, 1995	Substantially Equivalent	Merocel Corp.
K932176	BIOSIL MEDICAL GRADE SILICONE SHEETING	Dec 02, 1993	Substantially Equivalent	Bioplexus Corp.
K911503	EXMOOR SILICONE RUBBER SHEET	Nov 19, 1991	Substantially Equivalent	Exmoor Plastics , Ltd.