Racz Neurostat RF Generator
FDA 510(k) K232632 · Epimed International
510(k) numberK232632
Submission
- Device name
- Racz Neurostat RF Generator
- Applicant
- Epimed International
Johnstown, NY, US - Received
- August 30, 2023
- Decision date
- May 24, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K231675 | OneRF Ablation SystemGXD · Traditional | Neuroone Medical Technologies Corp. | 12/06/2023SE |
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| K201610 | IonicRF GeneratorGXD · Traditional | Abbott Medical | 10/21/2020SE |
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| K171143 | Relievant Medsystems RF GeneratorGXD · Traditional | Relievant Medsystems | 08/18/2017SE |
| K170242 | MultiGen 2 RF Generator SystemGXD · Traditional | Stryker Corporation | 05/25/2017SE |
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| K072005 | RK Epidural NeedleBSP · Traditional | 02/07/2008SE |
| K053318 | RX Epidural NeedleBSP · Traditional | 02/17/2006SE |
| K051171 | Stingray Epidural Catheter ConnectorCAZ · Traditional | 08/26/2005SE |
| K051860 | Flexible Introducer Cannula, Model 135-1837MIA · Traditional | 08/22/2005SE |
| K043467 | Flexible Spinal NeedleBSP · Traditional | 03/31/2005SE |
| K041021 | RF Introduction CannulaGXI · Traditional | 09/16/2004SE |
| K041843 | Pencil Point NeedleBSP · Traditional | 08/24/2004SE |
Questions and answers
When was Racz Neurostat RF Generator cleared by the FDA?
Racz Neurostat RF Generator (K232632) received a 510(k) decision of Substantially Equivalent on May 24, 2024, 268 days after the submission was received.
What is the product code of K232632?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.