510(k) Report

Devices descending from K993415

105 later devices reach GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K220699Prestige Coil SystemBait USA, LLC202212
+10K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+10K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+11K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+12K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—