510(k) Report

510(k) · Cleared

Cleared

Intracept Flexible BI-Polar RF Probe and Easy Access Instrument Set, Model FG0018 (Probe), FG0036 (Instrument Set)

K100641510(k) SpecialCleared Mar 30, 201025-day reviewClass II21 CFR 878.4400

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

Relievant Medsystems · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 30, 2010 after a 25-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.

Decided
Mar 30, 2010
Review
25 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2026: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant cleared2022: 2 descendants cleared2010201520202025
  1. This deviceK100641 Intracept Flexible BI-Polar RF Probe and Easy Access Instrument Set…Relievant Medsystems · 2010
  2. Descendant · cites it directly · 7 of its ownK153272 INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016
  3. Descendant · 2 generations on · 4 of its ownK180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF…Relievant Medsystems · 2018
  4. Descendant · 2 generations on · 4 of its ownK170827 INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017
  5. Descendant · 3 generations on · 3 of its ownK190504 Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept…Relievant Medsystems · 2019
  6. Descendant · 4 generations on · 1 of its ownK213836 Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2016: 12017: 12018: 12019: 12022: 22025: 12026: 1
2016high 2 (2022) · low 0 (2020)2026

Most influential descendants

Showing 5 of 8 · See all
  • K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016 · cites it directly7descendants
  • K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems · 2018 · 2 generations on4descendants
  • K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017 · 2 generations on4descendants
  • K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve…Relievant Medsystems · 2019 · 3 generations on3descendants
  • K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc. · 2022 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K100641Intracept Flexible BI-Polar RF Probe and Easy Access Instrument Set, Model…Relievant Medsystems2010—
+1K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems2016—
+2K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems2018—
+2K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems2017—
+3K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept…Relievant Medsystems2019—
+4K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
201810
201910
202220
202510
202610
FIG. 1 — Lineage of K100641, 2010–2026Source: 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), 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 GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set
Named without a submission number
—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems20167

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?

  • Of its descendants, K153272 (Relievant Medsystems, 2016) has gone furthest, with 7 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

Indications for use as stated in the FDA summary.

More from Relievant Medsystems

6 FDA decisions under this applicant name. See the company

  • K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System…Relievant Medsystems · 2019
  • K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems · 2018
  • K171143Relievant Medsystems RF GeneratorRelievant Medsystems · 2017
  • K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems · 2017
  • K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument SetRelievant Medsystems · 2016

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https://510kreport.com/device/K100641 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100641: Intracept Flexible BI-Polar RF Probe and Easy Access Instrument Set, Model FG0018 (Probe), FG0036 (Instrument Set).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100641

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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