510(k) Report

Devices descending from K900198

28 later devices reach Dexon II Absorbable Surgical Suture, U.S.P. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992088Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery)1999146
+1K980610Dexon Rapid (Dexon R)Davis & Geck, Inc.19980—
+1K972566Dexon VioletDavis & Geck, Inc.199727—
+2K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated201810—
+2K180625Rondek PGA Suture (Beige or Violet)Rk Manufacturing Corporation20180—
+2K142822PLIASURE Polyglycolide Synthetic Absorbable SutureETHICON, Inc.20150—
+2K132348Tephaflex Braided SutureTepha, Inc.20130—
+2K120284Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with…Coloplast A/S201201
+2K100461PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical201051
+2K060801Dekna-Lok Model BP1000V2LTeleflex Medical20060—
+2K040282Atramat and Sorb-Fast Polyglycolic AcidInternacional Farmaceutica, S.A. DE C.V.20041—
+2K994001Polyglycolic AcidTrading Consultants and Distributors Intl., Inc.20000—
+3K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC20260—
+3K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC20260—
+3K230311HyperSutureThreadstone, LLC20234—
+3K191268Force Fiber SutureTeleflex Medical Incorporated20192—
+3K130737Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd.20142—
+3K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp.20131—
+3K063462Neatstitch Neatclose Suturing DeviceNeat Stitch, Ltd.20070—
+4K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+4K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+4K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+4K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical20240—
+4K234079HyperSuture Extension LineThreadstone, LLC20240—
+4K210675EasyWhipWinter Innovations, Inc.20211—
+4K142810WEGO-PGCL Absorbable Surgical Monofilament SutureFoosin Medical Supplies Inc., Ltd.20141—
+5K261021EasyWhip FamilyWinter Innovations, Inc.20260—
+5K173779Rexmono, PdrexSm Eng Co., Ltd.20180—