510(k) Report

Devices descending from K061037

21 later devices reach PDS Plus Antibacterial Suture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212380PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical SutureETHICON, Inc.202221
+1K183183VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II…ETHICON, Inc.201903
+1K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc.20158—
+1K113004PDS (TM) Barbed SuturesETHICON, Inc.201111
+1K100461PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical201051
+2K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.20250—
+2K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.20250—
+2K191361DemeDIOX Barbed Absorbable Surgical SutureDemetech Corporation20190—
+2K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc.201975
+2K130737Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd.20142—
+2K130083Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable SutureDemetech Corp.20131—
+3K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.20260—
+3K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™…ETHICON, Inc.20250—
+3K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical20240—
+3K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited.20241—
+3K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.20222—
+3K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.202011
+3K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.201901
+3K142810WEGO-PGCL Absorbable Surgical Monofilament SutureFoosin Medical Supplies Inc., Ltd.20141—
+4K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™…M/s. Meril Endo Surgery Private Limited.20250—
+4K173779Rexmono, PdrexSm Eng Co., Ltd.20180—