510(k) Report

Devices descending from K011105

5 later devices reach Suturtek Fastclose Fascia Closure Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063462Neatstitch Neatclose Suturing DeviceNeat Stitch, Ltd.20070—
+1K042897Autobahn Tissue Closure Device and Disposable CartridgeEthicon Endo-Surgery, Inc.20040—
+1K032468Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated20031—
+1K030227Suturtek Fastclose Suturing DeviceSuturtek Incorporated20032—
+2K082828Suturtek 360 Degree Sternal Closure DeviceSuturtek Incorporated20080—