Modified Porges Spec 5* Suprapubic Catheter
FDA 510(k) K901603 · Bivona Medical Technologies
510(k) numberK901603
Submission
- Device name
- Modified Porges Spec 5* Suprapubic Catheter
- Applicant
- Bivona Medical Technologies
Gary, IN, US - Received
- March 27, 1990
- Decision date
- May 4, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOB – Catheter, Suprapubic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
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|---|---|---|---|
| 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 |
More from Rusch, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952700 | SuperslickJOH · Traditional | 10/31/1995SE |
| K942025 | Burget Nasal StentLWF · Traditional | 10/27/1995SE |
| K944178 | Bivona Flextend Pediatric & Neonatal Tracheostromy TubesJOH · Traditional | 10/27/1994SE |
| K935053 | Bivona Nasal Turbinate StentLYA · Traditional | 07/01/1994SE |
| K933398 | Bivona Illuminated Endotracheal TubeBTR · Traditional | 10/06/1993SE |
| K931749 | Bivona(R) ICU Endotracheal TubeBTR · Traditional | 08/10/1993SE |
| K922665 | Bivona Hyperflex Tracheostomy TubeJOH · Traditional | 01/07/1993SE |
| K923878 | Bivona Customized Tracheostomy TubesJOH · Traditional | 12/29/1992SE |
| K920604 | Bivona Tracheal T-Tube StentBTO · Traditional | 07/27/1992SE |
| K915761 | Bivona-Colorado Voice ProsthesisEWL · Traditional | 06/29/1992SE |
Questions and answers
When was Modified Porges Spec 5* Suprapubic Catheter cleared by the FDA?
Modified Porges Spec 5* Suprapubic Catheter (K901603) received a 510(k) decision of Substantially Equivalent on May 4, 1990, 38 days after the submission was received.
What is the product code of K901603?
The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.