Sexton Cystotomy Urine Pump
FDA 510(k) K843158 · Holter-Hausner Intl.
510(k) numberK843158
Submission
- Device name
- Sexton Cystotomy Urine Pump
- Applicant
- Holter-Hausner Intl.
Mchenry, IL, US - Received
- August 10, 1984
- Decision date
- October 4, 1984
- 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 |
|---|---|---|
| K875287 | H-H Flushing ReservoirJXG · Traditional | 07/14/1988SE |
| K874508 | H-H External Ventricular Drainage Collection BagJXG · Traditional | 01/19/1988SE |
| K872293 | H-H Hunter Active Tendon Implant BCHXA · Traditional | 09/28/1987SN |
| K872285 | H-H Hunter Active Tendon Implant DCHXA · Traditional | 09/28/1987SN |
| K872284 | H-H Hunter Active Tendon Implant PCHXA · Traditional | 09/28/1987SN |
| K871351 | H-H Harris Neonatal Nasal Cannula Set for CPAPBZD · Traditional | 05/14/1987SE |
| K870660 | H-H External Ventricular Drain (Evd) Comp./SystemsJXG · Traditional | 05/01/1987SE |
| K865075 | H-H Subgaleal TrocarGYK · Traditional | 01/13/1987SE |
| K853437 | H-H Hunter Tendon Rod · Traditional | 10/16/1985SE |
| K853436 | H-H Hunter Passive Tendon ImplantHXR · Traditional | 10/16/1985SE |
Questions and answers
When was Sexton Cystotomy Urine Pump cleared by the FDA?
Sexton Cystotomy Urine Pump (K843158) received a 510(k) decision of Substantially Equivalent on October 4, 1984, 55 days after the submission was received.
What is the product code of K843158?
The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.