510(k) Report

Devices descending from K851684

5 later devices reach Urotec/Franklin Soft Simplastic Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963993Rusch Simplastic Foley Catheterization SetRusch, Inc.19964—
+2K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc.20172—
+2K082919UC-Care Positioning SystemUc-Care Medical Systems, Ltd.20080—
+3K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc.20231—
+4K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.20260—