510(k) · Cleared

Cleared

GFX Nerve Ablation System

K063753510(k) TraditionalCleared Jun 20, 2007183-day reviewClass II21 CFR 882.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aci, Inc. · GXD Generator, Lesion, Radiofrequency

Cleared on Jun 20, 2007 as substantially equivalent to K965182 (Radionics, Inc., 1997) and 1 other predicate after a 183-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Jun 20, 2007
Review: 183 days
Class: Class II
Product code: GXD
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K965182 (1997). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK965182 RFG-3CFRadionics, Inc. · 1997
This deviceK063753 GFX Nerve Ablation SystemAci, Inc. · 2007
Descendant · cites it directly · 0 of its ownK081729 Modification to GFX Nerve Ablation SystemBioform Medical, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K081729Modification to GFX Nerve Ablation SystemBioform Medical, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K965182	RFG-3CF	Radionics, Inc.	1997	—
0 (this device)	K063753	GFX Nerve Ablation System	Aci, Inc.	2007	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K063753, 1997–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K965182	RFG-3CF Summary page 1 …: Class II E. Device Code: GXD (proposed) (21 CFR 882.4400) PREDICATE DEVICES Trade Name: Radionics RFG-3CF 510(k) Number: K965182 Trade Name: Mercury Medical Disposable RF Cannula 5 10(k) Number: K000073 DEVICE DESCRIPTION GFX Nerve Ablatio…	Radionics, Inc.	1997	—
*	K000073	Mercury Medical Disposable Radiofrequency Cannula Summary page 1 …82.4400) PREDICATE DEVICES Trade Name: Radionics RFG-3CF 510(k) Number: K965182 Trade Name: Mercury Medical Disposable RF Cannula 5 10(k) Number: K000073 DEVICE DESCRIPTION GFX Nerve Ablation System (generator and probe): The GFX Nerve Ablation System provides a minimall…	Mercury Medical	2000	1

Also cleared against K965182: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081729	Modification to GFX Nerve Ablation System	Bioform Medical, Inc.	2008	0

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K081729 (Bioform Medical, Inc., 2008) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K965182.

How does its category compare?

All GXD devices

GXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GXD

1in 2025

2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXD

185in 2007

2007high 185 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXD

1in 2023

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXD

88in 2025

2007high 195 (2019) · low 10 (2007)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/K063753 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063753: GFX Nerve Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063753

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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