Lowsley Suprapubic Tractor
FDA 510(k) K012153 · Circon Video
510(k) numberK012153
Submission
- Device name
- Lowsley Suprapubic Tractor
- Applicant
- Circon Video
Santa Barbara, CA, US - Received
- July 11, 2001
- Decision date
- September 19, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
More from Harry A. Schlakman
| 510(k) | Device | Decision |
|---|---|---|
| K012758 | Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models…FGB · Traditional | 04/09/2002SE |
| K011876 | Dolphin II Fluid Management System, Model DOL-2HIG · Traditional | 01/08/2002SE |
| K011849 | MICRO-6-SERIES (MR-6, MR-6L) Ureteroscopes, MRO-6 Series (MR-633, MR-642) Ureteroscopes…FGB · Traditional | 12/10/2001SE |
| K012929 | Flexible Pediatric Cystoureteroscope, Model Aur- 735FAJ · Traditional | 11/19/2001SE |
| K012951 | APN-2 USA Series Flexible CholedochoscopeFGB · Traditional | 11/09/2001SE |
| K012925 | DUR-8, Models DUR-8FGB · Traditional | 11/07/2001SE |
| K012265 | Metal Halide Light Source, Models MV-9088-T, MV-9088FCW · Traditional | 10/17/2001SE |
| K011848 | Circon AEH-4 Electrohydraulic Lithotripsy ProbeFFK · Traditional | 09/11/2001SE |
| K970595 | Circon Endotek OM-4 H2O Cystometry PumpFEN · Traditional | 10/24/1997SE |
| K914883 | Circon Acmi Gen Surg Instru for Mini Invasive SurgGEI · Traditional | 01/15/1993SE |
Questions and answers
When was Lowsley Suprapubic Tractor cleared by the FDA?
Lowsley Suprapubic Tractor (K012153) received a 510(k) decision of Substantially Equivalent on September 19, 2001, 70 days after the submission was received.
What is the product code of K012153?
The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.