510(k) Report

Devices descending from K153076

4 later devices reach silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical20201—
+1K193530Deklene MAXXTeleflex Medical20200—
+1K162396SILK Surgical SutureTeleflexmedical, Inc.20160—
+2K241111AMT Suture PasserApplied Medical Technology, Inc.20240—