Rusch Supraflex Suprapubic Cystostomy Catheter Kit, Sterile
FDA 510(k) K952187 · Rusch, Inc.
510(k) numberK952187
Submission
- Device name
- Rusch Supraflex Suprapubic Cystostomy Catheter Kit, Sterile
- Applicant
- Rusch, Inc.
Jeffrey, NH, US - Received
- May 9, 1995
- Decision date
- July 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K010420 | Rusch Mmg/O'Neil CatheterFCM · Traditional | 05/09/2001SE |
| K993528 | Rusch Emergency MaskCBP · Traditional | 05/31/2000SE |
| K993194 | Rusch Manual Resuscitator BagBTM · Traditional | 03/24/2000SE |
| K980870 | Rusch Silicone Foley CatheterEZL · Traditional | 06/09/1998SE |
| K974419 | Rusch Simplastic Councill Tip CatheterEZL · Traditional | 01/27/1998SE |
| K963779 | Rusch Enteral Feeding TubeFPD · Traditional | 05/23/1997SE |
| K970021 | Rusch Suprapubic TrayKOB · Traditional | 02/07/1997SE |
| K963993 | Rusch Simplastic Foley Catheterization SetFCM · Traditional | 12/17/1996SE |
| K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileJOH · Traditional | 06/28/1996SE |
| K955495 | Rusch Reinforced Trachael Tube Cuffed, SterileBTR · Traditional | 06/27/1996SE |
Questions and answers
When was Rusch Supraflex Suprapubic Cystostomy Catheter Kit, Sterile cleared by the FDA?
Rusch Supraflex Suprapubic Cystostomy Catheter Kit, Sterile (K952187) received a 510(k) decision of Substantially Equivalent on July 25, 1995, 77 days after the submission was received.
What is the product code of K952187?
The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.