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 Ureteral Access Catheter, Pediatric Ureteral Catheter
FDA 510(k) clearance K171662 · decided 2018-02-01
Clearance details
- K-number
- K171662
- Device name
- 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 Ureteral Access Catheter, Pediatric Ureteral Catheter
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2017-06-05
- Decision date
- 2018-02-01
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- KOD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Rubber Utility Catheter (K251864) | C.R. Bard, Inc. | 2026-02-23 |
| Wellead Ureteral Catheter (K220036) | Well Lead Medical Co., Ltd. | 2022-12-16 |
| allFlex Ureteral Catheters, Krait Ureteral Catheters (K220730) | Allwin Medical Devices, Inc. | 2022-10-13 |
| Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (K211032) | Urogen Pharma, Ltd. | 2021-11-19 |
| Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (K181979) | Teleflexmedical, Inc. | 2019-05-24 |
| UroGen Ureteral Catheter (K180354) | Urogen Pharma, Ltd. | 2018-10-30 |
| Angled Tip Ureteral Catheter (K181144) | Cook Incorporated | 2018-06-28 |
| Imager II Urology Torque Catheter (K180530) | Boston Scientific Corporation | 2018-04-10 |
| Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (K171810) | Cook Incorporated | 2018-03-07 |
| Renal Access Cobra Catheter, Kumpe Access Catheter (K171600) | Cook Incorporated | 2018-02-16 |
| GentleCath Intermittent Urinary Catheter (K172924) | Convatec Limited | 2017-11-21 |
| GentleCath Glide Intermittent Catheter (K161344) | Convatec Limited | 2016-09-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005) | Cook Incorporated | 2009-04-02 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006) | Cook Incorporated | 2009-03-05 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004) | Cook Incorporated | 2008-05-08 |
| COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002) | Cook Incorporated | 2000-06-12 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001) | Cook Incorporated | 1998-07-08 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007) | Cook Incorporated | 1994-09-30 |