FDA 510(k) Applications Submitted by Carly Powell
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180028 |
01/03/2018 |
Cook 810 Set, Desilets-Hoffman Introducer Set |
Cook Incorporated |
| K180756 |
03/22/2018 |
Safety Wire Guide Introducer |
COOK Incorporated |
| K181431 |
06/01/2018 |
Laser Ureteral Catheter |
Cook Incorporated |
| K171662 |
06/05/2017 |
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ure |
Cook Incorporated |
| K191498 |
06/05/2019 |
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc |
Cook Incorporated |
| K182066 |
08/01/2018 |
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set |
Cook Incorporated |
| K172588 |
08/29/2017 |
Balloon Catheter and Balloon Ureteral Dilator Set |
Cook Incorporated |
| K182709 |
09/27/2018 |
One-Step Suprapubic Introducer |
Cook Incorporated |
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