510(k) Report

Devices descending from K042431

2 later devices reach PROCON2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122003Renew InsertRenew Medical, Inc.20121—
+2K243367Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)Minnesota Medical Technologies20250—