510(k) Report

Devices descending from K081613

5 later devices reach Sparc System / Monarc, Monarc C, Monarc + Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131229Sparc System and Monarc, Monarc, and Monarc C SystemsAmerican Medical Systems201301
+1K132655Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc.20133—
+2K183134ArcTV Transvaginal Sling SystemUrocure, LLC20192—
+3K222293ArcSP Suprapubic Sling SystemUrocure, LLC20220—
+3K222468ArcTO Transobturator Sling SystemUrocure, LLC20220—