Radionics RF Disc Catheter Electrode System
FDA 510(k) K001741 · Radionics, Inc.
510(k) numberK001741
Submission
- Device name
- Radionics RF Disc Catheter Electrode System
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- June 8, 2000
- Decision date
- October 23, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRX – Arthroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1100
- Specialty
- Orthopedic
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | Karl Storz SE & CO. KG | 08/26/2026SE |
| K252790 | Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional | Clarus Medical, LLC | 05/26/2026SE |
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| K250795 | Purevue FMSHRX · Traditional | W.O.M. World of Medicine GmbH | 12/05/2025SE |
| K252666 | Articulator Arthroscopic BurHRX · Traditional | Joint Preservation Innovations, LLC | 11/21/2025SE |
| K252458 | Kyphoplasty Balloon Dilatation CathetersHRX · Traditional | Shanghai Lange Medtech Co., Ltd. | 11/03/2025SE |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional | Hand Biomechanics Lab, Inc. | 10/15/2025SE |
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| K001950 | Optical Tracking System (Ots)HAW · Special | 07/26/2000SE |
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| K001431 | Modification to Optical Tracking System (Ots)HAW · Special | 05/17/2000SE |
| K000057 | Radionics Lumboperitoneal ShuntJXG · Traditional | 03/20/2000SE |
| K993594 | Conformax MMLC VR1IYE · Special | 12/15/1999SE |
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Questions and answers
When was Radionics RF Disc Catheter Electrode System cleared by the FDA?
Radionics RF Disc Catheter Electrode System (K001741) received a 510(k) decision of Substantially Equivalent on October 23, 2000, 137 days after the submission was received.
What is the product code of K001741?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.