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KHJ — Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) Class II

FDA Device Classification

Classification Details

Product Code
KHJ
Device Class
Class II
Regulation Number
874.3620
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232646cook biotech incorporatedBiodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic BuMay 24, 2024
K161000cook biotech incorporatedBiodesign Otologic Repair GraftMay 11, 2016
K150594cook biotech incorpratedBiodesign Otologic Repair GraftSeptember 16, 2015
K132198ceremedADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAISeptember 12, 2013
K121360cook biotech incorpratedBIODESIGN ENT REPAIR GRAFTFebruary 27, 2013
K122561ceremedADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINNovember 27, 2012
K120220ceremedADAPTAIN SOLUBLE IMPLANT MATERIALJune 6, 2012
K103047ceremedCERETENE SOLUBLE IMPLANT MATERIALJanuary 5, 2011
K080022vascular solutionsGEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USPDecember 9, 2008
K082245ceremedAOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LVSeptember 18, 2008
K081531ceremedAOC SOLUBLE IMPLANT MATERIALJuly 18, 2008
K070093ceremedOSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTEJanuary 24, 2007
K062280ceremedOSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTEDecember 11, 2006
K060561cambridgemedCLEARADEX GELMay 30, 2006
K060878curamedicalGELITA-SPON ABSORBABLE GELATIN SPONGE, USPApril 13, 2006
K051487doctor research groupDRG LARYNGEAL AUGMENTATION IMPLANT DEVICEDecember 22, 2005
K051911curamedicalGELITA-SPONDecember 6, 2005
K043035genzyme corporationSEPRAGEL ENT BIORESORBABLE PACKING/STENTJuly 11, 2005
K033796heinz kurz gmbh medizintechnikKURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BSJanuary 30, 2004
K013243bioformCOAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1January 9, 2002