510(k) Report

Devices descending from K043258

3 later devices reach Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211072Safety Trocar CannulaBoston Scientific Corporation20210—
+1K180725Aspire Introducer NeedleAspire Bariatrics, Inc.20180—
+1K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc.20071—