510(k) Report

Devices descending from K802093

5 later devices reach Gabbay-Frater Suture Guide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…Teleflexmedical, Inc.20164—
+2K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical20201—
+2K193530Deklene MAXXTeleflex Medical20200—
+2K162396SILK Surgical SutureTeleflexmedical, Inc.20160—
+3K241111AMT Suture PasserApplied Medical Technology, Inc.20240—