510(k) Report

Devices descending from K953264

41 later devices reach Questus Polyester Suture Soft Tissue Anchor System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970292IN-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone ScrewInfluence, Inc.1997401
+2K011910IN-Fast Bone Screw SystemAmerican Medical Systems, Inc.20010—
+2K981677Repose Bone Screw SystemInfluence, Inc.1999162
+2K972622Straight-in Bone Screw Fixation SystemInfluence, Inc.199714—
+2K972023Sleep-in Bone Screw SystemInfluence, Inc.199723—
+3K122391Medtronic Xomed, Inc.Medtronic Xomed, Inc.20134—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc.201015—
+3K040417Pillar Palatal Implant SystemRestore Medical, Inc.20040—
+3K011723Anti-Snoring Device or AsdPi Medical20024—
+3K020446Modification to Straight-in Bone Screw Fixation SystemAmerican Medical Systems, Inc.20020—
+3K982155Short Straight-in Bone Screw Fixation SystemInfluence, Inc.199812—
+4K183310Encore SystemSiesta Medical, Inc.20192—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K133680Encore SystemSiesta Medical, Inc.20143—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K110623Pillar Palatal Implant SystemMedtronic Xomed, Inc.20122—
+4K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc.201014—
+4K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.2006103
+4K990095Straight-in-Orthopedic Bone Screw Fixation SystemInfluence, Inc.19990—
+5K201238Encore SystemSiesta Medical, Inc.20201—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K181107Elevo® Kit Snoring Intervention DeviceZelegent, Inc.20181—
+5K182169AdVance XP Male SlingBoston Scientific Corporation20182—
+5K110127Prelude Iii Tongue Suspension SystemSiesta Medical, Inc.201113—
+5K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC20085—
+5K063079I-Stop Trans Obturator Male SlingCl Medical20060—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K213475Elevo Snoring Intervention SetZelegent, Inc.20220—
+6K213159Encore SystemSiesta Medical, Inc.20210—
+6K211847AdVance XP Male Sling SystemBoston Scientific Corporation20211—
+6K111179Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue…Siesta Medical, Inc.20116—
+6K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S20103—
+6K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S20094—
+7K242960AdVance™ XP Male Sling System (720163-03)Boston Scientific Corporation20240—
+7K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc.20124—
+7K121814Encore Tongue Suspension SystemSiesta Medical, Inc.20120—
+7K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121—
+7K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110—
+8K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast20230—