510(k) Report

510(k) · Cleared

Cleared

Atricure Bipolar Coagulation System

K011722510(k) TraditionalCleared Aug 30, 200187-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

AtriCure, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 30, 2001 as substantially equivalent to K973384 (ETHICON, Inc., 1997) and 14 other predicates after an 87-day review. Its family tree reaches back 4 generations to 1995. 92 later devices descend from it.

Decided
Aug 30, 2001
Review
87 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
15

Its longest line of descent runs back 4 generations to K942299 (1995). 30 ancestors in all, the oldest K811390 (1981). 92 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 3 other ancestors1999: 3 other ancestors1998: 3 other ancestors1997: 7 other ancestors1995: 4 other ancestors1994: 1 other ancestor1988: 1 other ancestor1981: 1 other ancestor1996: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor2004: 3 descendants cleared2008: 10 descendants cleared2002: 1 descendant cleared2006: 10 descendants cleared2011: 4 descendants cleared2003: 1 descendant cleared2005: 2 descendants cleared2007: 4 descendants cleared2010: 3 descendants cleared2012: 7 descendants cleared2009: 3 descendants cleared2021: 2 descendants cleared2022: 3 descendants cleared2019: 8 descendants cleared2018: 5 descendants cleared2014: 5 descendants cleared2013: 2 descendants cleared2025: 2 descendants cleared2024: 6 descendants cleared2020: 2 descendants cleared2017: 1 descendant cleared2016: 1 descendant cleared2015: 1 descendant cleared2026: 4 descendants cleared2023: 2 descendants clearedK942299 · Endocare Cryotherapy System · Cytocare, Inc. · 1995K963826 · Endocare Crycare Cryosurgical System · Endocare, Inc. · 1996×2: 2 generations cleared close together, K973686 (1997), K980110 (1998) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors2 generations back: 7 other ancestors3 generations back: 5 other ancestors 1 generation forward: 4 descendants2 generations forward: 10 descendants3 generations forward: 18 descendants4 generations forward: 21 descendants5 generations forward: 18 descendants6 generations forward: 10 descendants7 generations forward: 4 descendants8 generations forward: 4 descendants9 generations forward: 3 descendants K980110 · 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. · 19950+5
  1. Root · 4 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
  2. 3 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
  3. 2 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
  4. 1 generation backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
  5. This deviceK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
  6. Descendant · cites it directly · 90 of its ownK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
  7. Descendant · 2 generations on · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
  8. Descendant · 2 generations on · 34 of its ownK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
  9. Descendant · cites it directly · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
  10. Descendant · 2 generations on · 22 of its ownK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 32005: 22006: 102007: 42008: 102009: 32010: 32011: 42012: 72013: 22014: 52015: 12016: 12017: 12018: 52019: 82020: 22021: 22022: 32023: 22024: 62025: 22026: 4
2002high 10 (2006) · low 1 (2002)2026

Most influential descendants

Showing 5 of 92 · See all
  • K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002 · cites it directly90descendants
  • K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · 2 generations on42descendants
  • K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003 · 2 generations on34descendants
  • K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · cites it directly23descendants
  • K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc. · 2006 · 2 generations on22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K942299Endocare Cryotherapy SystemCytocare, Inc.1995—
−3K963826Endocare Crycare Cryosurgical SystemEndocare, Inc.1996—
−2K973686Endocare Cryocare Cryosurgical SystemEndocare, Inc.1997—
−1K980110Endocre Cryocare Cryosurgical SystemEndocare, Inc.1998—
0 (this device)K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.2001—
+1K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.2002—
+2K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2004—
+2K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular2003—
+1K022894Epicor Medical Ablation SystemEpicor Medical, Inc.2004—
+2K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and…Cryocath Technologies, Inc.20061

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199110
199210
199410
199540
199610
199770
199830
199930
200030

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200430
200520
2006100
200740
2008100
200930
201030
201140
201270
201320
201450
201510
201610
201710
201850
201980
202020
202120
202230
202320
202460
202520
202640
FIG. 1 — Lineage of K011722, 1995–2026Source: 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
Get a 510(k) Report

What was it cleared against? (15)

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
*K973384Ethicon Non-Stick Bipolar Forceps
Summary page 1
…gulation System Generic/Common Name: Electrosurgical cutting and coagulation device and Accessories 21CFR878.4400 Predicate Devices Ethicon Non-Stick Bipolar Forceps (K973384) Link Technology’s Non-Stick Bipolar Forceps (K992931). The generator accessory is equivalent to the currently marketed Rita Mo…
ETHICON, Inc.1997—
*K992931Non-Stick Bipolar Forceps
Summary page 1
…tting and coagulation device and Accessories 21CFR878.4400 Predicate Devices Ethicon Non-Stick Bipolar Forceps (K973384) Link Technology’s Non-Stick Bipolar Forceps (K992931). The generator accessory is equivalent to the currently marketed Rita Model 1500 Electrosurgical RF Generator, which received c…
Silverglide Surgical Technologies1999—
*K993944Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive…
Summary page 1
…Bipolar Forceps (K992931). The generator accessory is equivalent to the currently marketed Rita Model 1500 Electrosurgical RF Generator, which received clearance under K993944 Somnus Medical Technologies Model S1 Electrosurgical Generator KO0O0501 Symbiosis Bipolar Forceps (K950286 and K951387) Kirwan M…
Rita Medical Systems1999—
*K000501Electrosurgical Generator, Model S1Somnus Medical Technologies, Inc.2000—
*K950286Symbiosis Bipolar Scissors
Summary page 1
…0 Electrosurgical RF Generator, which received clearance under K993944 Somnus Medical Technologies Model S1 Electrosurgical Generator KO0O0501 Symbiosis Bipolar Forceps (K950286 and K951387) Kirwan Medical Bipolar Forceps (K945975 and K955001) CardioThoracic Systems MIDCAB/SVH Bipolar Forceps (K963930) H…
Symbiosis Corp.1995—
*K951387Symbiosis Bipolar Scissors
Summary page 1
…gical RF Generator, which received clearance under K993944 Somnus Medical Technologies Model S1 Electrosurgical Generator KO0O0501 Symbiosis Bipolar Forceps (K950286 and K951387) Kirwan Medical Bipolar Forceps (K945975 and K955001) CardioThoracic Systems MIDCAB/SVH Bipolar Forceps (K963930) Heartport Inc…
Symbiosis Corp.1995—
*K945975Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps
Summary page 1
…ce under K993944 Somnus Medical Technologies Model S1 Electrosurgical Generator KO0O0501 Symbiosis Bipolar Forceps (K950286 and K951387) Kirwan Medical Bipolar Forceps (K945975 and K955001) CardioThoracic Systems MIDCAB/SVH Bipolar Forceps (K963930) Heartport Inc. Heartport Maze System (K970496) EndoCar…
Everest Medical Corp.1994—
*K955001Evershears Scissors, Bilap Probes, Bicoag Forceps
Summary page 1
…3944 Somnus Medical Technologies Model S1 Electrosurgical Generator KO0O0501 Symbiosis Bipolar Forceps (K950286 and K951387) Kirwan Medical Bipolar Forceps (K945975 and K955001) CardioThoracic Systems MIDCAB/SVH Bipolar Forceps (K963930) Heartport Inc. Heartport Maze System (K970496) EndoCare Cryocare C…
Everest Medical Corp.1995—
*K963930CTS Midcab/SVH Bipolar Scissors
Summary page 1
…erator KO0O0501 Symbiosis Bipolar Forceps (K950286 and K951387) Kirwan Medical Bipolar Forceps (K945975 and K955001) CardioThoracic Systems MIDCAB/SVH Bipolar Forceps (K963930) Heartport Inc. Heartport Maze System (K970496) EndoCare Cryocare Cryosurgical System (KS880110) 10 CyroGen Cardiac Cryosurgica…
Cardiothoracic Systems, Inc.1997—
*K970496Heartport Maze System: Cryoprobe Set
Summary page 1
…286 and K951387) Kirwan Medical Bipolar Forceps (K945975 and K955001) CardioThoracic Systems MIDCAB/SVH Bipolar Forceps (K963930) Heartport Inc. Heartport Maze System (K970496) EndoCare Cryocare Cryosurgical System (KS880110) 10 CyroGen Cardiac Cryosurgical Unit (K974320) 11.CyroGen Cryosurgical Unit…
Heartport, Inc.1997—
*K980110Endocre Cryocare Cryosurgical System
Our OCR of the scanned summary read K880110, FDA’s number for Cystine Tryptic Medium W/Dextrose (Hardy Media). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “EndoCare Cryocare Cryosurgical System”.
Endocare, Inc.1998—
*K974320Cryogen Cardiac Cryosurgical System
Summary page 1
…CAB/SVH Bipolar Forceps (K963930) Heartport Inc. Heartport Maze System (K970496) EndoCare Cryocare Cryosurgical System (KS880110) 10 CyroGen Cardiac Cryosurgical Unit (K974320) 11.CyroGen Cryosurgical Unit and Accessories (KO03050) 12.Galil Medical Cryo-Hit 200(K991517) 13. Galil Medical Cryo-Hit (K99…
Cryogen, Inc.1998—
*K003050Cryosurgical Unit and AccessoriesCryogen, Inc.2000—
*K991517Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
Summary page 1
…are Cryosurgical System (KS880110) 10 CyroGen Cardiac Cryosurgical Unit (K974320) 11.CyroGen Cryosurgical Unit and Accessories (KO03050) 12.Galil Medical Cryo-Hit 200(K991517) 13. Galil Medical Cryo-Hit (K993965) LCeNOOAE b~ 44 AtriCure Incorporated Bipolar Coagulation System 510(k}…
Galil Medical, Ltd.1999—
*K993965Cryo-Hit
Summary page 1
…CyroGen Cardiac Cryosurgical Unit (K974320) 11.CyroGen Cryosurgical Unit and Accessories (KO03050) 12.Galil Medical Cryo-Hit 200(K991517) 13. Galil Medical Cryo-Hit (K993965) LCeNOOAE b~ 44 AtriCure Incorporated Bipolar Coagulation System 510(k} Indication For Use Statement The Atri…
Galil Medical, Ltd.2000—

Also cleared against K973384: 2 other devices →

What descends from it? (92)

See all 92

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

NumberDeviceApplicantDecidedDescendants
K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.200290
K022894Epicor Medical Ablation SystemEpicor Medical, Inc.200423
K082954Encage Bipolar RF ProbeTrod Medical SA20080
K061544Stellartech 100 Coagulation SystemStellartech Research Corp.20060

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 6 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
  • 1 of the 30 ancestors has a recall of any class.
  • Of its descendants, K020919 (AtriCure, Inc., 2002) has gone furthest, with 90 descendants of its own.
  • 2 other devices also cite its predicate K973384.

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.

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 AtriCure Bipolar Coagulation System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K973384

2 other devices cite the same predicate.

  • K091259Ethicon Endo-Surgery Flexible Bipolar Hemostasis ForcepsEthicon Endo-Surgery, Inc. · 2010
  • K982705Midas Touch Bipolar ForcepsIti Medical Technologies, Inc. · 19981 recall

More from AtriCure, Inc.

97 FDA decisions under this applicant name. See the company

  • K263319ACHM30 AtriClip FLEX-Mini LAA Exclusion SystemAtriCure, Inc. · 2026
  • P100046/S021Synergy Ablation SystemAtriCure, Inc. · 2026
  • P200002/S015EPi- Sense ST Coagulation SystemAtriCure, Inc. · 2026
  • P100046/S020Synergy Ablation SystemAtriCure, Inc. · 2026
  • P200002/S014EPi-Sense and EPi-Sense ST Guided Coagulation SystemAtriCure, Inc. · 2026

Recent decisions in GEI

The GEI category page

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  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K011722 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011722: Atricure Bipolar Coagulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011722

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026