FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
K Number: K060397
·
Decision Aug 31, 2006
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
65
Applicant Total
44
Review Days
197
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
- K Number
- K060397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4725
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PAJUNK GmbH Medizintechnologie
- Date Received
- February 15, 2006
- Decision Date
- August 31, 2006
- Product Code
- GXI
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXI), ordered by most recent decision date.
Disposable Radiofrequency Cannula
FDA 510(k)
FDA Class 2
·Neurology
STAR RF Ablation System
FDA 510(k)
FDA Class 2
·Neurology
OneRF Trigeminal Nerve Radiofrequency Probes
FDA 510(k)
FDA Class 2
·Neurology
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
FDA 510(k)
FDA Class 2
·Neurology
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
FDA 510(k)
FDA Class 2
·Neurology
RF Cannula
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by PAJUNK GmbH Medizintechnologie
| K Number | Device Name | ||
|---|---|---|---|
| K243690 | SonoMSK | Jul 1, 2025 | Substantially Equivalent |
| K243682 | SonoPlex STIM; SonoPlex II | Jun 27, 2025 | Substantially Equivalent |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | Jun 25, 2025 | Substantially Equivalent |
| K243525 | SonoTAP and SonoTAP II | Mar 24, 2025 | Substantially Equivalent |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | Nov 22, 2024 | Substantially Equivalent |
| K241954 | SonoBlock; SonoBlock II | Sep 11, 2024 | Substantially Equivalent |
| K230701 | Stim2Go | Nov 24, 2023 | Substantially Equivalent |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | Feb 22, 2023 | Substantially Equivalent |
| K220897 | Disposable Brain Biopsy Needle 2.0 | Aug 17, 2022 | Substantially Equivalent |
| K202699 | E-Cath STIM acc. Tsui | Dec 29, 2020 | Substantially Equivalent |