KARL STORZ Monopolar Resectoscopes with HF Cable
FDA 510(k) K232486 · Karl Storz SE & CO. KG
510(k) numberK232486
Submission
- Device name
- KARL STORZ Monopolar Resectoscopes with HF Cable
- Applicant
- Karl Storz SE & CO. KG
Tuttlingen, DE - Received
- August 16, 2023
- Decision date
- May 7, 2024
- 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
Other 510(k)s with product code FJL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was KARL STORZ Monopolar Resectoscopes with HF Cable cleared by the FDA?
KARL STORZ Monopolar Resectoscopes with HF Cable (K232486) received a 510(k) decision of Substantially Equivalent on May 7, 2024, 265 days after the submission was received.
What is the product code of K232486?
The FDA product code is FJL – Resectoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.