510(k) Report

Devices descending from K905482

16 later devices reach Bondek Polyglycolic Acid Synthetic Absorb. Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992088Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery)1999146
+1K991191Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery)1999151
+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—
+2K120284Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with…Coloplast A/S201201
+2K060801Dekna-Lok Model BP1000V2LTeleflex Medical20060—
+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—
+4K254275HyperSuture All Green Extension LineThreadstone, LLC20260—
+4K242201HyperSuture White/Green Extension LineThreadstone, LLC20251—
+4K241376HyperSuture All Blue Extension LineThreadstone, LLC20240—
+4K234079HyperSuture Extension LineThreadstone, LLC20240—
+4K210675EasyWhipWinter Innovations, Inc.20211—
+5K261021EasyWhip FamilyWinter Innovations, Inc.20260—