510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Mercury Medical Disposable Radiofrequency Cannula

K000073510(k) TraditionalCleared Mar 1, 200051-day reviewClass II21 CFR 882.4725Recalls 1

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

Mercury Medical · GXI Probe, Radiofrequency Lesion

Cleared on Mar 1, 2000 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.

Decided
Mar 1, 2000
Review
51 days
Class
Class II
Product code
GXI
Recalls
1
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2026: 1 descendant cleared2008: 1 descendant cleared200020052010201520202025
  1. This deviceK000073 Mercury Medical Disposable Radiofrequency CannulaMercury Medical · 2000
  2. Descendant · cites it directly · 1 of its ownK063753 GFX Nerve Ablation SystemAci, Inc. · 2007
  3. Descendant · cites it directly · 0 of its ownK253907 Disposable Radiofrequency CannulaAbbott Medical · 2026
  4. Descendant · 2 generations on · 0 of its ownK081729 Modification to GFX Nerve Ablation SystemBioform Medical, Inc. · 2008

Most influential descendants

Showing 3 of 3 · See all
  • K063753GFX Nerve Ablation SystemAci, Inc. · 2007 · cites it directly1descendant
  • K253907Disposable Radiofrequency CannulaAbbott Medical · 2026 · cites it directly0descendants
  • K081729Modification to GFX Nerve Ablation SystemBioform Medical, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000073Mercury Medical Disposable Radiofrequency CannulaMercury Medical2000—
+1K063753GFX Nerve Ablation SystemAci, Inc.2007—
+1K253907Disposable Radiofrequency CannulaAbbott Medical2026—
+2K081729Modification to GFX Nerve Ablation SystemBioform Medical, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
202610
FIG. 1 — Lineage of K000073, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GXI? 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 GXI device

  1. #1 K253907 Disposable Radiofrequency Cannulascore 12.7 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063753GFX Nerve Ablation SystemAci, Inc.20071
K253907Disposable Radiofrequency CannulaAbbott Medical20260

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 26, 2013Class IIZ-1247-2016Process controlStraight needle labeled as a curved needle

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K063753 (Aci, Inc., 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GXI devices

GXI Probe, Radiofrequency Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXI

4in 2025

2007: 42008: 22009: 22010: 22011: 32012: 12013: 12014: 12015: 12016: 32017: 32018: 12019: 32020: 32022: 22025: 42026 (partial year): 2
2007high 4 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXI

183in 2025

2007: 87 days median2011: 64 days median2016: 240 days median2017: 125 days median2019: 63 days median2020: 255 days median2025: 183 days median
2007high 255 (2020) · low 63 (2019)2026

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

Recalls per year · GXI

1in 2019

2007: 32008: 12010: 12012: 12013: 12017: 12019: 12026 (partial year): 3
2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · GXI

98in 2025

2007: 12008: 42009: 102010: 82011: 52012: 142013: 252014: 202015: 232016: 162017: 1502018: 1472019: 932020: 312021: 302022: 462023: 352024: 452025: 98
2007high 150 (2017) · low 1 (2007)2025

MAUDE reports naming product code GXI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200748731
20082—14
20092—010
20102—18
201136405
20121—114
20131—125
20141—020
20151—023
20163240016
201731251150
20181—0147
2019363193
20203255031
20210—030
20222—046
20230—035
20240—045
20254183098
20262—3—
Cite this page

510(k) Report. “K000073: Mercury Medical Disposable Radiofrequency Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000073

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026