Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical System
FDA 510(k) K120127 · Swan Valley Medical, Incorporated
510(k) numberK120127
Submission
- Device name
- Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical System
- Applicant
- Swan Valley Medical, Incorporated
Golden, CO, US - Received
- January 17, 2012
- Decision date
- October 26, 2012
- 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 |
| 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 |
Questions and answers
When was Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical System cleared by the FDA?
Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical System (K120127) received a 510(k) decision of Substantially Equivalent on October 26, 2012, 283 days after the submission was received.
What is the product code of K120127?
The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.