510(k) Report

Devices descending from K101060

15 later devices reach Siesta Medical, Inc., Prelude Tongue Suspension System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc.201014—
+2K110127Prelude Iii Tongue Suspension SystemSiesta Medical, Inc.201113—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K111179Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue…Siesta Medical, Inc.20116—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc.20124—
+4K121814Encore Tongue Suspension SystemSiesta Medical, Inc.20120—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K133680Encore SystemSiesta Medical, Inc.20143—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K183310Encore SystemSiesta Medical, Inc.20192—
+7K201238Encore SystemSiesta Medical, Inc.20201—
+8K213159Encore SystemSiesta Medical, Inc.20210—