Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
FDA 510(k) K191341 · Corinth Medtech, Inc.
510(k) numberK191341
Submission
- Device name
- Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- Applicant
- Corinth Medtech, Inc.
Cupertino, CA, US - Received
- May 20, 2019
- Decision date
- June 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FJL – Resectoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FJL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232486 | KARL STORZ Monopolar Resectoscopes with HF CableFJL · Traditional | Karl Storz SE & CO. KG | 05/07/2024SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | Karl Storz Endoscopy America, Inc. | 03/17/2023SE |
| K230205 | Veloxion SystemFJL · Special | Corinth Medtech, Inc. | 02/24/2023SE |
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion…FJL · Traditional | Corinth Medtech, Inc. | 03/15/2019SE |
| K162979 | Veloxion SystemFJL · Traditional | Corinth Medtech, Inc. | 03/24/2017SE |
| K102663 | AED ResectoscopeFJL · Traditional | National Advanced Endoscopy Devices, Inc. | 12/30/2010SE |
| K062720 | S-Line Bipolar Resectoscopes and Bipolar ElectrodesFJL · Traditional | Richard Wolf Medical Instruments Corp. | 03/22/2007SE |
| K042523 | Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, AccessoriesFJL · Traditional | Richard Wolf Medical Instruments Corp. | 03/18/2005SE |
| K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207FJL · Traditional | Richard Wolf Medical Instruments Corp. | 08/19/2004SE |
| K001270 | Gyrus Endourology System: Axipolar Resectoscope Loop ElectrodeFJL · Special | Gyrus Medical , Ltd. | 04/28/2000SE |
More from Gyrus Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K230205 | Veloxion SystemFJL · Special | 02/24/2023SE |
| K191335 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…HIH · Special | 06/06/2019SE |
| K190113 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…HIH · Traditional | 04/24/2019SE |
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion…FJL · Traditional | 03/15/2019SE |
| K180752 | Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid…HIH · Traditional | 07/25/2018SE |
| K162979 | Veloxion SystemFJL · Traditional | 03/24/2017SE |
Questions and answers
When was Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags cleared by the FDA?
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (K191341) received a 510(k) decision of Substantially Equivalent on June 13, 2019, 24 days after the submission was received.
What is the product code of K191341?
The FDA product code is FJL – Resectoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.