510(k) Report

Devices descending from K060743

9 later devices reach Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123743Ultrasafe Plus Passive Needle GuardSafety Syringes, Inc.20133—
+1K122558Ultrasafe Passive Needle GuardSafety Syringes, Inc.20124—
+1K112936Safe'sound Luer Lock Passive Devlivery SystemRexam Consummer Plastics Inc.D/B/A Rexam Pharma20120—
+1K101233Safe'n'sound Passive Delivery SystemRexam Pharma20115—
+2K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.20230—
+2K141664Safe'n'sound Staked Passive Delivery System - Cone VersionRexam Healthcare20141—
+2K141464Novaguard S a Safety SystemWest Pharmaceutical Services20141—
+3K163511NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc.20170—
+3K150562Safe'n'Sound Staked Passive Delivery System - Plajex versionNemera20150—