510(k) Report

Devices descending from K003404

2 later devices reach Suprasperm System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S201613
+2K241833V-GRADVitromed GmbH20250—