510(k) Report

Devices descending from K953013

16 later devices reach Merocel Reinforced Silicone Sheets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970910Xomed Silicone Block/StripXomed, Inc.199715—
+2K982294Xomed Silicone Pre-Form BlocksXomed, Inc.199812—
+2K972317Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc.199714—
+3K013243Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1Bioform, Inc.2002111
+3K991324Titanium Vocal Fold Medializing Implant, Models 5001 001 (Female), and 5001 003 (Male)Heinz Kurz19990—
+4K081816Vocalis and Vocalis SMCytophil, Inc.20090—
+4K081815Vocalis GelCytophil, Inc.20090—
+4K070090Radiesse Laryngeal ImplantBioform Medical, Inc.20075—
+4K033398Laryngeal Augmentation ImplantBioform, Inc.200310—
+5K180631Silk VoiceSofregen Medical, Inc.20181—
+5K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc.20130—
+5K071663VF Gel PlusCoapt Systems, Inc.20084—
+5K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc.200661
+6K240919Silk Voice (SMI-04)Sofregen Medical20240—
+6K080956Modification to VF Gel PlusCoapt Systems, Inc.20083—
+7K083783VF LiquigelCoapt Systems, Inc.20090—