510(k) · Cleared

Cleared

Incircle BI-Polar RF Ablation System

K070711510(k) TraditionalCleared Apr 24, 200741-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

Rfa Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 24, 2007 as substantially equivalent to K040785 (Boston Scientific Corp, 2004) and 3 other predicates after a 41-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.

Decided: Apr 24, 2007
Review: 41 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K010060 (2001). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK010060 Rita Starburst Xli Electrosurgical DeviceRita Medical Systems · 2001 · Recalled
This deviceK070711 Incircle BI-Polar RF Ablation SystemRfa Medical, Inc. · 2007
Descendant · cites it directly · 2 of its ownK070443 Intracept BI-Polar RF Probe, Model 04814Relievant Medsystems, Inc. · 2007
Descendant · 2 generations on · 0 of its ownK083856 Intracept Flexible BI-Polar RF Probe and Curved Instrument Set…Relievant Medsystems, Inc. · 2009
Descendant · cites it directly · 0 of its ownK082954 Encage Bipolar RF ProbeTrod Medical SA · 2008

Most influential descendants

Showing 3 of 3 · See all

K070443Intracept BI-Polar RF Probe, Model 04814Relievant Medsystems, Inc. · 2007 · cites it directly2descendants
K083856Intracept Flexible BI-Polar RF Probe and Curved Instrument Set, Models: FG0018, FG0026Relievant Medsystems, Inc. · 2009 · 2 generations on0descendants
K082954Encage Bipolar RF ProbeTrod Medical SA · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010060	Rita Starburst Xli Electrosurgical Device	Rita Medical Systems	2001	3
0 (this device)	K070711	Incircle BI-Polar RF Ablation System	Rfa Medical, Inc.	2007	—
+1	K070443	Intracept BI-Polar RF Probe, Model 04814	Relievant Medsystems, Inc.	2007	—
+2	K083856	Intracept Flexible BI-Polar RF Probe and Curved Instrument Set, Models…	Relievant Medsystems, Inc.	2009	—
+1	K082954	Encage Bipolar RF Probe	Trod Medical SA	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0

FIG. 1 — Lineage of K070711, 2001–2009Source: 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 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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (4)

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
*	K040785	Concerto Bipolar Needle Electrode Summary page 2 …The RFA Medical InCircle' TM Bi-Polar RF Ablation System is substantially equivalent to the Boston Scientific ConcertoTM Bipolar Needle Electrode (K040785, K050361, and K060419) and Rita Medical Systems StarBurstTM Xli Electrosurgical Device (K010060). The InCircle has a simi…	Boston Scientific Corp	2004	—
*	K050361	Modification to Concerto Bipolar Needle Electrode Summary page 2 …e RFA Medical InCircle' TM Bi-Polar RF Ablation System is substantially equivalent to the Boston Scientific ConcertoTM Bipolar Needle Electrode (K040785, K050361, and K060419) and Rita Medical Systems StarBurstTM Xli Electrosurgical Device (K010060). The InCircle has a similar inten…	Boston Scientific Corp	2005	—
*	K060419	Concerto Bipolar Needle Electrode Summary page 2 …InCircle' TM Bi-Polar RF Ablation System is substantially equivalent to the Boston Scientific ConcertoTM Bipolar Needle Electrode (K040785, K050361, and K060419) and Rita Medical Systems StarBurstTM Xli Electrosurgical Device (K010060). The InCircle has a similar intended u…	Boston Scientific Corp	2006	—
*	K010060	Rita Starburst Xli Electrosurgical Device Summary page 2 …he Boston Scientific ConcertoTM Bipolar Needle Electrode (K040785, K050361, and K060419) and Rita Medical Systems StarBurstTM Xli Electrosurgical Device (K010060). The InCircle has a similar intended use, materials of construction, and principles of operation as the predicate…	Rita Medical Systems	2001	3

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K070443	Intracept BI-Polar RF Probe, Model 04814	Relievant Medsystems, Inc.	2007	2
K082954	Encage Bipolar RF Probe	Trod Medical SA	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 4 ancestors has a recall of any class.
Of its descendants, K070443 (Relievant Medsystems, Inc., 2007) has gone furthest, with 2 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. 2007, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

The RFA Medical InCircleTM Bi-Polar RF Ablation System 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.

https://510kreport.com/device/K070711 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070711: Incircle BI-Polar RF 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/K070711

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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