Catheter, Suprapubic (And Accessories)
FDA product code KOB · Class II (moderate risk) · 21 CFR 876.5090 · Gastroenterology, Urology
32510(k) clearances
0PMA approvals
4recalls
Implantimplanted device
Manufacturers
- Cook, Inc. 3
- Rusch, Inc. 2
- Cook Urological, Inc. 2
- Van-Tec, Inc. 2
- Vance Products Incorporated 2
- Porges Corp. 1
- Applied Medical Technology, Inc. 1
- Harry A. Schlakman 1
- Dentmed , Ltd. 1
- Olympus Corp. 1
- Phoenix Bioengineering, Inc. 1
- Teledyne Getz 1
- Bivona Medical Technologies 1
- Femcare , Ltd. 1
- Advanced Surgical Intervention, Inc. 1
- Angiomed U.S., Inc. 1
- Cook Ob/Gyn 1
- Franklin Medical USA, Inc. 1
- Holter-Hausner Intl. 1
- Burron Medical Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage SetKOB · Traditional | Applied Medical Technology, Inc. | 11/01/2024SE |
| K181097 | Cook Cystostomy Catheter SetKOB · Traditional | Cook Incorporated | 01/18/2019SESK |
| K182709 | One-Step Suprapubic IntroducerKOB · Traditional | Cook Incorporated | 12/26/2018SE |
| K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetKOB · Traditional | Cook Incorporated | 10/30/2018SESK |
| K132890 | Suprapubic Catheter and Introducer SetKOB · Traditional | Mediplus , Ltd. | 01/17/2014SE |
| K120127 | Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemKOB · Traditional | Swan Valley Medical, Incorporated | 10/26/2012SE |
| K014002 | All Silicone Supra-Pubia Catheter, Models 4880/4890KOB · Traditional | Fortune Medical Instrument Corp. | 03/04/2002SE |
| K012153 | Lowsley Suprapubic TractorKOB · Traditional | Circon Video | 09/19/2001SE |
| K970969 | Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional | The Kendal Co. | 04/23/1997SE |
| K970021 | Rusch Suprapubic TrayKOB · Traditional | Rusch, Inc. | 02/07/1997SE |
| K945480 | Moss(R) Steel Breakaway(R) IntroducerKOB · Traditional | Harry A. Schlakman | 08/28/1995SE |
| K953024 | Lindner/Golomb SP Introducing SoundKOB · Traditional | Cook Urological, Inc. | 08/18/1995SE |
| K952187 | Rusch Supraflex Suprapubic Cystostomy Catheter Kit, SterileKOB · Traditional | Rusch, Inc. | 07/25/1995SE |
| K921071 | DentolockKOB · Traditional | Dentmed , Ltd. | 03/26/1992SE |
| K904798 | Suprapubic Flow ControllerKOB · Traditional | Olympus Corp. | 11/22/1991SE |
| K904434 | Sexton Cystotomy Urine Pump (SCUP2)KOB · Traditional | Phoenix Bioengineering, Inc. | 02/01/1991SE |
| K901938 | Super Strength Denture Adhesive CreamKOB · Traditional | Teledyne Getz | 06/06/1990SE |
| K901603 | Modified Porges Spec 5* Suprapubic CatheterKOB · Traditional | Bivona Medical Technologies | 05/04/1990SE |
| K884061 | Add-A-CathKOB · Traditional | Femcare , Ltd. | 10/25/1988SE |
| K881097 | Spec 5* Suprapubic CatheterKOB · Traditional | Porges Corp. | 06/03/1988SE |
| K874530 | Urethral Dilator EndoscopeKOB · Traditional | Advanced Surgical Intervention, Inc. | 01/27/1988SE |
| K870556 | Van-Tec C-Flex Suprapubic Balloon Catheter SetKOB · Traditional | Van-Tec, Inc. | 03/10/1987SE |
| K870555 | Van-Tec Pediatric Suprapubic Catheter SetKOB · Traditional | Van-Tec, Inc. | 03/10/1987SE |
| K863386 | Vesico Suprapubic Bladder Drainage & Exchange SetsKOB · Traditional | Angiomed U.S., Inc. | 10/24/1986SE |
| K863120 | (Stamey) T.U.R.P. Suprapubic Catheter SetKOB · Traditional | Cook Urological, Inc. | 10/24/1986SE |
| K852287 | Percutaneous Pigtail Suprapublic Catheter SetKOB · Traditional | Cook Ob/Gyn | 08/08/1985SE |
| K852200 | Simplastic Supra Pubic CatheterKOB · Traditional | Franklin Medical USA, Inc. | 08/07/1985SE |
| K843158 | Sexton Cystotomy Urine PumpKOB · Traditional | Holter-Hausner Intl. | 10/04/1984SE |
| K813084 | Cystofix Suprapubic Bladder Drain SetKOB · Traditional | Burron Medical Products, Inc. | 12/31/1981SE |
| K810368 | Vance Percutaneous Malecot NephrostomyKOB · Traditional | Vance Products, Inc. | 03/20/1981SE |
| K800607 | Suprapubic TrocarKOB · Traditional | G.D. Searle and Co. | 04/08/1980SE |
| K780765 | Percutaneous Surapubic CatheterKOB · Traditional | Vance Products, Inc. | 07/17/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1370-2019 Class II | Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr -…Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for… | Cook Inc. | 04/22/2019Terminated |
| Z-1369-2019 Class II | Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500…Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for… | Cook Inc. | 04/22/2019Terminated |
| Z-0969-2020 Class II | Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | Cook Inc. | 01/04/2019Terminated |
| Z-0968-2020 Class II | Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire… | Cook Inc. | 01/04/2019Terminated |