Vance Percutaneous Malecot Nephrostomy
FDA 510(k) K810368 · Vance Products, Inc.
510(k) numberK810368
Submission
- Device name
- Vance Percutaneous Malecot Nephrostomy
- Applicant
- Vance Products, Inc.
Walker, MI, US - Received
- February 12, 1981
- Decision date
- March 20, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K820313 | Vpi-Fair Urethral StentKOD · Traditional | 03/01/1982SE |
| K812995 | Vance-Jacobellis Microhematuria CatheterKOD · Traditional | 03/01/1982SE |
| K813278 | Vpi Ureteral Dilatation Ballon CatheterEZN · Traditional | 12/18/1981SE |
| K812785 | Vance-Ambrose Resectoscope ForcepsGEN · Traditional | 11/16/1981SE |
| K812057 | Vance CystoscopicFBK · Traditional | 07/31/1981SE |
| K811833 | Vnace Fascial Dilator SetKOE · Traditional | 07/10/1981SE |
| K811454 | Vance Prostatic Aspiration SetKNW · Traditional | 06/09/1981SE |
| K810372 | Vance Deflectable Biopsy Brush SetKOD · Traditional | 03/20/1981SE |
| K810371 | Vance Urethal Dilator SetKOE · Traditional | 03/20/1981SE |
| K810370 | Pollack Chain Cysourethrogram SetFGI · Traditional | 03/20/1981SE |
Questions and answers
When was Vance Percutaneous Malecot Nephrostomy cleared by the FDA?
Vance Percutaneous Malecot Nephrostomy (K810368) received a 510(k) decision of Substantially Equivalent on March 20, 1981, 36 days after the submission was received.
What is the product code of K810368?
The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.