510(k) · Cleared
ClearedModification to GFX Nerve Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioform Medical, Inc. · GXD Generator, Lesion, Radiofrequency
Cleared on Aug 7, 2008 as substantially equivalent to K063753 (Aci, Inc., 2007) and 1 other predicate after a 50-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Aug 7, 2008
- Review
- 50 days
- Class
- Class II
- Product code
- GXD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K965182 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K965182 | RFG-3CF | Radionics, Inc. | 1997 | — |
| −1 | K063753 | GFX Nerve Ablation System | Aci, Inc. | 2007 | — |
| 0 (this device) | K081729 | Modification to GFX Nerve Ablation System | Bioform Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GXD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXD device
- #1 K251247 GX1 Radiofrequency Generator Kit…score 11.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063753 | GFX Nerve Ablation SystemSummary page 1…5. Substantial Equivalence The following are the predicate devices that are substantially equivalent to the GFX Nerve Ablation System: 510(k) Number: K063753 Device: GFX Nerve Ablation System BioForm Medical (formerly ACI) 4133 Courtney Rd., Ste. 10 Franksville, WI 5… | 2007 |
| * | K965182 | RFG-3CFSummary page 1…umber: K063753 Device: GFX Nerve Ablation System BioForm Medical (formerly ACI) 4133 Courtney Rd., Ste. 10 Franksville, WI 53126 510(k) Number: K965182 Device: Radionics RFG-3CF Radionics, Inc. 22 Terry Avenue Burlington, MA 01803 6. Summary of… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All GXD devicesGXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GXD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXD
185in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXD
88in 2025
MAUDE reports naming product code GXD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 185 | 0 | 10 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 1 | — | 1 | 69 |
| 2011 | 2 | — | 0 | 89 |
| 2012 | 0 | — | 0 | 77 |
| 2013 | 0 | — | 0 | 119 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 0 | 67 |
| 2016 | 0 | — | 1 | 51 |
| 2017 | 2 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 156 |
| 2019 | 1 | — | 1 | 195 |
| 2020 | 2 | — | 0 | 138 |
| 2021 | 0 | — | 0 | 154 |
| 2022 | 1 | — | 0 | 84 |
| 2023 | 2 | — | 1 | 54 |
| 2024 | 2 | — | 0 | 63 |
| 2025 | 1 | — | 0 | 88 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat lesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081729 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081729: Modification to GFX Nerve Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081729
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026