510(k) Report

Devices descending from K111392

2 later devices reach Woojeon Acupuncture Needle (=Sera Acupuncture Needle) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141473SMC Acupuncture NeedleSmc Intl., Inc.20141—
+2K162566AIK Sterile Acupuncture Needles for Single UseChangchun Aik Medical Devices Co., Ltd.20170—