510(k) Report

Devices descending from K030212

12 later devices reach Monodek Synthetic Absorbable Surgical Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810—
+1K120284Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with…Coloplast A/S201201
+2K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC20260—
+2K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+2K230311HyperSutureThreadstone, LLC20234—
+2K191268Force Fiber SutureTeleflex Medical Incorporated20192—
+3K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+3K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+3K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+3K234079HyperSuture Extension LineThreadstone, LLC20240—
+3K210675EasyWhipWinter Innovations, Inc.20211—
+4K261021EasyWhip FamilyWinter Innovations, Inc.20260—