510(k) Report

Devices descending from K000665

8 later devices reach TFX Medical Safety Needle with Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043258Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical20043—
+1K041708Enpath Safety IntroducerEnpath Medical Incorporated20040—
+1K022099Safe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'SHdc Corp.20020—
+1K021034Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc.20024—
+1K020985Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc.20020—
+2K211072Safety Trocar CannulaBoston Scientific Corporation20210—
+2K180725Aspire Introducer NeedleAspire Bariatrics, Inc.20180—
+2K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc.20071—