510(k) Report

Devices descending from K974311

13 later devices reach Vocom (Vocal Cord Medialization) Implant through their predicates, nearest generation first.

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