510(k) Report

Devices descending from K140085

6 later devices reach Universa Percultaneous Drainage Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits…Coloplast Corp.20220—
+1K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane…Cook Incorporated20200—
+1K181735Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent SetCook Incorporated201902
+1K181097Cook Cystostomy Catheter SetCook Incorporated20191—
+1K180029Malecot Nephrostomy Catheter/Stent SetCook Incorporated20180—
+2K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.20240—