Veloxion System
FDA 510(k) K230205 · Corinth Medtech, Inc.
510(k) numberK230205
Submission
- Device name
- Veloxion System
- Applicant
- Corinth Medtech, Inc.
San Jose, CA, US - Received
- January 25, 2023
- Decision date
- February 24, 2023
- 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 |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…FJL · Special | Corinth Medtech, Inc. | 06/13/2019SE |
| 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 |
|---|---|---|
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…FJL · Special | 06/13/2019SE |
| 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 System cleared by the FDA?
Veloxion System (K230205) received a 510(k) decision of Substantially Equivalent on February 24, 2023, 30 days after the submission was received.
What is the product code of K230205?
The FDA product code is FJL – Resectoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.