510(k) Report

Devices descending from K070065

17 later devices reach Ams Single Incision Sling System (Sis-0) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100807Miniarc Precise Single-Incision Sling System Model: 720181, 720191American Medical Systems, Inc.20102—
+1K071902Ams Miniarc Sling SystemAmerican Medical Systems, Inc.200716—
+2K121641Miniarc Pro Single-Incision Sling SystemAmerican Medical Systems201201
+2K110420Ophira Mini Sling SystemPromedon S.A20120—
+2K073703Ams Miniarc Sling SystemAmerican Medical Systems, Inc.200815—
+3K121562Altis Single Incision Cling SystemColoplast A/S20122—
+3K103418Desara MiniCaldera Medical, Inc.20110—
+3K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.20091—
+3K081275Boston Scientific Surgical MeshBoston Scientific Corp20085—
+4K221874Altis Single Incision Sling SystemColoplast A/S20231—
+4K172565Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device…Boston Scientific Corporation20170—
+4K103022KIMNeomedic International S.L.20110—
+4K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd.20090—
+4K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc.200932
+5K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…Coloplast Corp.20240—
+5K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc.20110—
+5K101440GMD Universal Urinary Incontinence Sling, Model 1012Generic Medical Devices, Inc.20101—