FDA.reportPublic FDA data

510(k) K232646

Device
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
Applicant
Cook Biotech Incorporated
510(k) number
K232646
Product code
KHJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-24
Date received
2023-08-30
Regulation
874.3620
Classification name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Christopher Lotzow
Address
1425 Innovation Pl. West Lafayette IN US 47906 47906

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KHJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K161000Biodesign Otologic Repair GraftCook Biotech Incorporated2016-05-11
K150594Biodesign Otologic Repair GraftCook Biotech Incorprated2015-09-16
K132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.2013-09-12
K121360BIODESIGN ENT REPAIR GRAFTCook Biotech Incorprated2013-02-27
K122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , Inc.2012-11-27
K120220ADAPTAIN SOLUBLE IMPLANT MATERIALCeremed , Inc.2012-06-06
K103047CERETENE SOLUBLE IMPLANT MATERIALCeremed , Inc.2011-01-05
K080022GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USPVascular Solutions, Inc.2008-12-09
K082245AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LVCeremed , Inc.2008-09-18
K081531AOC SOLUBLE IMPLANT MATERIALCeremed , Inc.2008-07-18
K070093OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTECeremed , Inc.2007-01-24
K062280OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTECeremed , Inc.2006-12-11
K060561CLEARADEX GELCambridgemed2006-05-30
K060878GELITA-SPON ABSORBABLE GELATIN SPONGE, USPCuramedical, BV2006-04-13
K051487DRG LARYNGEAL AUGMENTATION IMPLANT DEVICEDoctor'S Research Group, Inc.2005-12-22