S-Line Bipolar Resectoscopes and Bipolar Electrodes
FDA 510(k) K062720 · Richard Wolf Medical Instruments Corp.
510(k) numberK062720
Submission
- Device name
- S-Line Bipolar Resectoscopes and Bipolar Electrodes
- Applicant
- Richard Wolf Medical Instruments Corp.
Vernon Hills, IL, US - Received
- September 12, 2006
- Decision date
- March 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Questions and answers
When was S-Line Bipolar Resectoscopes and Bipolar Electrodes cleared by the FDA?
S-Line Bipolar Resectoscopes and Bipolar Electrodes (K062720) received a 510(k) decision of Substantially Equivalent on March 22, 2007, 191 days after the submission was received.
What is the product code of K062720?
The FDA product code is FJL – Resectoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.