510(k) Report

Devices descending from K043456

11 later devices reach Modification to Soaker Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation20144—
+1K060933Solace Post-Operative Pain Relief Infusion SystemApex Medical Technologies, Inc.20060—
+1K051401ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterI-Flow Corp.20054—
+2K171193Certa CatheterFerrosan Medical Devices Sp. Z.O.O.20170—
+2K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitHalyard Health20160—
+2K152952E-CathPAJUNK GmbH Medizintechnologie20161—
+2K111031Painfusor CatheterPlan 1 Health, S.R.L.20111—
+2K080675Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie20082—
+2K072702Stryker Antimic CatheterStryker Instruments, Instruments Div.20080—
+3K202699E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie20200—
+3K193664SubQKath Catheter and Needle SetHk Surgical20200—