Cystofix Suprapubic Bladder Drain Set
FDA 510(k) K813084 · Burron Medical Products, Inc.
510(k) numberK813084
Submission
- Device name
- Cystofix Suprapubic Bladder Drain Set
- Applicant
- Burron Medical Products, Inc.
Mchenry, IL, US - Received
- November 2, 1981
- Decision date
- December 31, 1981
- 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
Other 510(k)s with product code KOB
| 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 |
More from Rusch, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K870403 | Cavafix(R) Central Venous Catheter Kit W/SutureFOZ · Traditional | 05/01/1987SE |
| K862412 | IntestoplantLLD · Traditional | 11/13/1986SE |
| K861479 | Cavafix, Central Venous Catheter KitFOZ · Traditional | 07/01/1986SESD |
| K860126 | Stimuplex, Nerve StimulatorBXN · Traditional | 02/28/1986SE |
| K851293 | ImplantofixLJT · Traditional | 01/09/1986SE |
| K841428 | Jejunostomy Set for Tube FeedingKNT · Traditional | 07/09/1984SE |
| K834383 | Dual-Lumen Long Term Central Venous CatLJS · Traditional | 05/01/1984SE |
| K834299 | Long Term Central Venous Access CathLJS · Traditional | 05/01/1984SE |
| K834473 | Multi-Lumen Central Venous Cath. KitLJS · Traditional | 04/30/1984SE |
| K840179 | Continuous Epidural Anesthes. TrayCAZ · Traditional | 02/24/1984SE |
Questions and answers
When was Cystofix Suprapubic Bladder Drain Set cleared by the FDA?
Cystofix Suprapubic Bladder Drain Set (K813084) received a 510(k) decision of Substantially Equivalent on December 31, 1981, 59 days after the submission was received.
What is the product code of K813084?
The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.