510(k) Report

510(k) · Cleared

Cleared

Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip

K122276510(k) SpecialCleared Aug 29, 201230-day reviewClass II21 CFR 878.4300

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

AtriCure, Inc. · FZP Clip, Implantable

Cleared on Aug 29, 2012 as substantially equivalent to K093679 (AtriCure, Inc., 2010) after a 30-day review. Its family tree reaches back 10 generations to 1993. 15 later devices descend from it.

Decided
Aug 29, 2012
Review
30 days
Class
Class II
Product code
FZP
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K933887 (1993). 65 ancestors in all, the oldest K771412 (1977). 15 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2003: 6 other ancestors2001: 4 other ancestors1999: 1 other ancestor1997: 4 other ancestors2002: 3 other ancestors2000: 5 other ancestors1995: 3 other ancestors1993: 1 other ancestor1977: 1 other ancestor1998: 3 other ancestors1996: 7 other ancestors1994: 5 other ancestors1992: 4 other ancestors1991: 1 other ancestor1989: 2 other ancestors1984: 1 other ancestor1982: 1 other ancestor1985: 1 other ancestor2015: 1 descendant cleared2016: 2 descendants cleared2014: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant cleared2018: 2 descendants cleared2019: 1 descendant cleared2021: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant cleared2026: 2 descendants clearedK933887 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 1993K962043 · Auto Suture Modified VCS Clip Applier · United States Surgical, A Division of Tyco Healthc · 1996 · recalledK994160 · Coalescent Surgical Sutured-Clip · Coalescent Surgical · 2000×6: 6 generations cleared close together, K012317 (2001), K013664 (2002), K021407 (2002), K023125 (2002), K024366 (2003), K031623 (2003) K093679 · Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide Model Various LAA0 · AtriCure, Inc. · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 5 other ancestors3 generations back: 6 other ancestors4 generations back: 10 other ancestors5 generations back: 22 other ancestors6 generations back: 8 other ancestors7 generations back: 4 other ancestors 1 generation forward: 5 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 3 descendants8 generations forward: 2 descendants K093679 · Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide Model Various LAA0 · AtriCure, Inc. · 2010K031623 · Modification to Coalescent Surgical U-Clip and Accessories · Coalescent Surgical · 2003 · recalledK024366 · Coalescent Surgical U-Clip and Accessories · Coalescent Surgical · 2003 · recalledK023125 · Coalescent U-Clip- and Accessories · Coalescent Surgical · 2002K021407 · Coalescent Surgical U-Clip - or Other TBD and Accessories · Coalescent Surgical · 2002K013664 · Coalescent Surgical U-Clip · Coalescent Surgical · 2002K012317 · Coalescent Surgical U-Clip · Coalescent Surgical · 2001K994160 · Coalescent Surgical Sutured-Clip · Coalescent Surgical · 2000K962043 · Auto Suture Modified VCS Clip Applier · United States Surgical, A Division of Tyco Healthc · 1996 · recalledK933887 · Implantable Clip · United States Surgical, A Division of Tyco Healthc · 1993−10−50+5
  1. Root · 10 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 6 generations between
  3. 3 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  4. 2 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  5. 1 generation backK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
  6. This deviceK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012
  7. Descendant · cites it directly · 10 of its ownK153500 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V…AtriCure, Inc. · 2016
  8. Descendant · 2 generations on · 9 of its ownK173031 AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017
  9. Descendant · 3 generations on · 8 of its ownK180010 AtriClip FLEX-VAtriCure, Inc. · 2018
  10. Descendant · 4 generations on · 7 of its ownK181474 ArtiClip LAA Exclusion SystemAtriCure, Inc. · 2018
  11. Descendant · 5 generations on · 6 of its ownK191413 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2019
Show all 10 generations
  1. Root · 10 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
  2. 9 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
  3. 8 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
  4. 7 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
  5. 6 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
  6. 5 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
  7. 4 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
  8. 3 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  9. 2 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
  10. 1 generation backK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
  11. This deviceK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 12016: 22017: 12018: 22019: 12021: 12022: 12023: 22026: 2
2013high 2 (2016) · low 0 (2020)2026

Most influential descendants

Showing 5 of 15 · See all
  • K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc. · 2016 · cites it directly10descendants
  • K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017 · 2 generations on9descendants
  • K180010AtriClip FLEX-VAtriCure, Inc. · 2018 · 3 generations on8descendants
  • K181474ArtiClip LAA Exclusion SystemAtriCure, Inc. · 2018 · 4 generations on7descendants
  • K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc. · 2019 · 5 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K933887Implantable ClipUnited States Surgical, A Division of Tyco Healthc1993—
−9K962043Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc19967
−8K994160Coalescent Surgical Sutured-ClipCoalescent Surgical2000—
−7K012317Coalescent Surgical U-ClipCoalescent Surgical2001—
−6K013664Coalescent Surgical U-ClipCoalescent Surgical2002—
−5K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical2002—
−4K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical2002—
−3K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20031
−2K031623Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20034
−1K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc.2010—
0 (this device)K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.2012—
+1K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.2016—
+2K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.2017—
+3K180010AtriClip FLEX-VAtriCure, Inc.2018—
+4K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.2018—
+5K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip…AtriCure, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
198210
198410
198510
198920
199110
199240
199310
199450
199530
199670
199740
199830
199910
200050
200140
200230
200360
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201510
201620
201710
201820
201910
202110
202210
202320
202620
FIG. 1 — Lineage of K122276, 1993–2026Source: 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 FZP? 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 FZP device

  1. #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 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? (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
*K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…
Summary page 1
…es. Cleared Device The device proposed for modification in this submission is the AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip cleared via 510(k) K093679 on June 10, 2010. Device Description The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implanta…
AtriCure, Inc.2010—

Also cleared against K093679: 4 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610
K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132
K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141
K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20160
K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150

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 19 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 12 of the 65 ancestors have a recall of any class.
  • Of its descendants, K153500 (AtriCure, Inc., 2016) has gone furthest, with 10 descendants of its own.
  • 4 other devices also cite its predicate K093679.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FZP

5in 2025

2007: 62008: 42009: 32010: 62011: 32012: 22013: 32014: 32015: 82016: 52017: 42018: 42019: 12020: 22022: 32023: 32024: 22025: 52026 (partial year): 2
2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007: 31 days median2008: 23 days median2009: 22 days median2010: 47 days median2011: 124 days median2013: 47 days median2014: 29 days median2015: 182 days median2016: 72 days median2017: 29 days median2018: 143 days median2022: 227 days median2023: 65 days median2025: 90 days median
2007high 227 (2022) · low 22 (2009)2026

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

Recalls per year · FZP

1in 2020

2007: 12008: 62010: 12012: 12014: 12016: 22017: 12019: 32020: 1
2007high 6 (2008) · low 0 (2009)2026

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

Adverse event reports per year · FZP

1,902in 2025

2007: 1,8772008: 9812009: 2,1602010: 2,3672011: 1,6782012: 1,6772013: 2,3812014: 2,3202015: 2,8712016: 1,8402017: 2,5942018: 2,7182019: 2,9032020: 1,7602021: 1,7592022: 1,5752023: 1,9182024: 2,0672025: 1,902
2007high 2,903 (2019) · low 981 (2008)2025

MAUDE reports naming product code FZP, 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
200763111,877
20084236981
200932202,160
201064712,367
2011312401,678
20122—11,677
201334702,381
201432912,320
2015818202,871
201657221,840
201742912,594
2018414302,718
20191—32,903
20202—11,760
20210—01,759
2022322701,575
202336501,918
20242—02,067
202559001,902
20262—0—

What is it indicated for?

The AtriClip LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K093679

4 other devices cite the same predicate.

  • K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2017
  • K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2015
  • K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2014
  • K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc. · 2013

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 FZP

The FZP category page

  • K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L. · 2026
  • K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation · 2026
  • K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025
  • K253781InnoClip Clip ApplierTaiwan Surgical Corporation · 2025
  • K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025

https://510kreport.com/device/K122276 · printed Nov 4, 2026

Cite this page

510(k) Report. “K122276: Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122276

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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