510(k) Report

Devices descending from K051530

6 later devices reach Monarc + Subfascial Hammock, Model 72404193; Monarc C Subfascial Hammock… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081613Sparc System / Monarc, Monarc C, Monarc + SystemsAmerican Medical Systems, Inc.20085—
+2K131229Sparc System and Monarc, Monarc, and Monarc C SystemsAmerican Medical Systems201301
+2K132655Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc.20133—
+3K183134ArcTV Transvaginal Sling SystemUrocure, LLC20192—
+4K222293ArcSP Suprapubic Sling SystemUrocure, LLC20220—
+4K222468ArcTO Transobturator Sling SystemUrocure, LLC20220—