510(k) Report

510(k) · Cleared

Cleared

Encage Bipolar RF Probe

K082954510(k) TraditionalCleared Oct 17, 200814-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

Trod Medical SA · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 17, 2008 as substantially equivalent to K070711 (Rfa Medical, Inc., 2007) and 3 other predicates after a 14-day review. Its family tree reaches back 5 generations to 1995.

Decided
Oct 17, 2008
Review
14 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K942299 (1995). 48 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 2 other ancestors2003: 2 other ancestors2006: 1 other ancestor2005: 2 other ancestors2004: 3 other ancestors2001: 2 other ancestors2000: 6 other ancestors1999: 4 other ancestors1998: 3 other ancestors1997: 7 other ancestors1995: 4 other ancestors1994: 1 other ancestor1991: 2 other ancestors1988: 1 other ancestor1981: 1 other ancestor1996: 1 other ancestor1992: 1 other ancestorK942299 · Endocare Cryotherapy System · Cytocare, Inc. · 1995K963826 · Endocare Crycare Cryosurgical System · Endocare, Inc. · 1996×2: 2 generations cleared close together, K973686 (1997), K980110 (1998) K011722 · Atricure Bipolar Coagulation System · AtriCure, Inc. · 20011980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 20 other ancestors3 generations back: 12 other ancestors4 generations back: 8 other ancestors K011722 · Atricure Bipolar Coagulation System · AtriCure, Inc. · 2001K980110 · Endocre Cryocare Cryosurgical System · Endocare, Inc. · 1998K973686 · Endocare Cryocare Cryosurgical System · Endocare, Inc. · 1997K963826 · Endocare Crycare Cryosurgical System · Endocare, Inc. · 1996K942299 · Endocare Cryotherapy System · Cytocare, Inc. · 1995−50
  1. Root · 5 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
  2. 4 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
  3. 3 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
  4. 2 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
  5. 1 generation backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
  6. This deviceK082954 Encage Bipolar RF ProbeTrod Medical SA · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K942299Endocare Cryotherapy SystemCytocare, Inc.1995—
−4K963826Endocare Crycare Cryosurgical SystemEndocare, Inc.1996—
−3K973686Endocare Cryocare Cryosurgical SystemEndocare, Inc.1997—
−2K980110Endocre Cryocare Cryosurgical SystemEndocare, Inc.1998—
−1K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.2001—
0 (this device)K082954Encage Bipolar RF ProbeTrod Medical SA2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199120
199210
199410
199540
199610
199770
199830
199940
200060
200120
200320
200430
200520
200610
200720
FIG. 1 — Lineage of K082954, 1995–2008Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K070711Incircle BI-Polar RF Ablation System
Summary page 1
…assification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400) 5.5 Predicate devices - INCIRCLE Bi-Polar RF Ablation device (K070711) - INTRACEPT Bi-Polar RF Probe and Instrument Set (K070443) - ATRICURE Bi-Polar coagulation System (KO11722) -…
Rfa Medical, Inc.2007—
*K070443Intracept BI-Polar RF Probe, Model 04814
Summary page 1
…and accessories (21 CFR 878.4400) 5.5 Predicate devices - INCIRCLE Bi-Polar RF Ablation device (K070711) - INTRACEPT Bi-Polar RF Probe and Instrument Set (K070443) - ATRICURE Bi-Polar coagulation System (KO11722) - RITA STARBURST SDE electrosurgical device (K030967) 5.6 Device…
Relievant Medsystems, Inc.2007—
*K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.2001—
*K030967Rita Starburst Sde Electrosurgical Device
Summary page 1
…- INTRACEPT Bi-Polar RF Probe and Instrument Set (K070443) - ATRICURE Bi-Polar coagulation System (KO11722) - RITA STARBURST SDE electrosurgical device (K030967) 5.6 Device description The ENCAGE bipolar RF probe is a sterile, disposable, bi-polar, Radio Frequency (RF), hand-held electr…
Rita Medical Systems2003—

Also cleared against K070711: 1 other device →

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 13 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
  • 4 of the 48 ancestors have a recall of any class.
  • 1 other device also cites its predicate K070711.

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. 2008, 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 ENCAGE bipolar RF probe is intended to be used in conjunction with radiofrequency (RF) generators for percutaneous, laparoscopic, or intraoperative thermal coagulation of soft tissues.

Indications for use as stated in the FDA summary.

Also cleared against K070711

1 other device cites the same predicate.

  • K070443Intracept BI-Polar RF Probe, Model 04814Relievant Medsystems, Inc. · 2007

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
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  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K082954 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082954: Encage Bipolar RF Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082954

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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