510(k) K183335
- Device
- Medline Poly-Cath Red Polymer Urethral Catheter
- Applicant
- Medline Industries, Inc.
- 510(k) number
- K183335
- Product code
- KOD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-06-12
- Date received
- 2018-12-03
- Regulation
- 876.5130
- Classification name
- Catheter, Urological
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dinah Rincones
- Address
- Three Lakes Dr. Northfiled IL US 60093 60093
FDA Registration Numbers#
- 3006271008
- 3014404707
- 1423537
- 3007134520
- 1221765
- 3011987967
- 9616668
- 3014656749
- 3010400865
- 8022978
- 9680787
- 1000121056
- 2032112
- 9616088
- 9613662
- 1018233
- 1054241
- 3008729910
- 8043792
- 9710524
- 3010220595
- 2029015
- 1921846
- 3003903031
- 2124215
- 9611590
- 1055236
- 3004111573
- 1825146
- 3008191244
- 3008806809
- 9611712
- 3006606901
- 3030678884
- 3009337401
- 1820334
- 3011020307
- 1061124
- 9612030
- 3009732568
- 3010173425
- 1828132
- 3010288357
- 3015131144
- 3006371704
- 2320762
- 1043214
- 1718873
- 3022518300
- 3005099803
- 1424263
- 3006430057
- 3008102042
- 1000317571
- 1417592
- 3015176887
- 3005941719
- 9610694
- 2320961
- 3006082230
- 3017961114
- 3016761372
- 1480288
- 3008824097
- 9681260
- 8040233
- 3030671614
- 3016863553
- 3006536657
- 3011270181
- 3006405073
- 3016675012
- 3015142802
- 3006017180
- 3007738736
- 1932668
- 3005778470
- 3020976354
- 3008502431
- 3011137372
Source Documents#
Other 510(k) Records For Product Code KOD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251864 | Rubber Utility Catheter | C.R. Bard, Inc. | 2026-02-23 |
| K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | 2022-12-16 |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | Allwin Medical Devices, Inc. | 2022-10-13 |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma, Ltd. | 2021-11-19 |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | 2019-05-24 |
| K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | 2018-10-30 |
| K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | 2018-06-28 |
| K180530 | Imager II Urology Torque Catheter | Boston Scientific Corporation | 2018-04-10 |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Cook Incorporated | 2018-03-07 |
| K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated | 2018-02-16 |
| K171662 | 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 | Cook Incorporated | 2018-02-01 |
| K172924 | GentleCath Intermittent Urinary Catheter | Convatec Limited | 2017-11-21 |
| K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | 2016-09-20 |
| K160877 | United Urologics Closed System Catheter | Robling Medical, Inc. | 2016-05-20 |
| K140953 | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER | Convatec, Ltd. | 2014-08-01 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases