510(k) Report

Devices descending from K961697

5 later devices reach Opticon Female Urinary Incontinence Catheter for Continuous Drainage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023090Option-VF Urinary Catheter, FV14218Opticon Medical, Inc.200331
+1K970716Opticon Direct Male Urinary Catheter for Continuous DrainageOpticon Medical, Inc.19970—
+2K041983Option-VM Urinary Catheter/Adpater, Models MV39016, MVA39016Opticon Medical200411
+2K033830Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage…Opticon Medical, Inc.20042—
+3K062240CareventChief Medical, LLC20060—