510(k) · Cleared
Recalled · Class II · 2016AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AtriCure, Inc. · FZP Clip, Implantable
Cleared on Mar 18, 2016 as substantially equivalent to K122276 (AtriCure, Inc., 2012) after a 29-day review. Its family tree reaches back 11 generations to 1993. It has been recalled 2 times.
- Decided
- Mar 18, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 11 generations to K933887 (1993). 66 ancestors in all, the oldest K771412 (1977). No later device cites it as a predicate yet.
- Root · 11 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 7 generations between
- 3 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 2 generations backK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
- 1 generation backK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012
- This deviceK160454 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2016
Show all 11 generations
- Root · 11 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 10 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 9 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 8 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 7 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 6 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 5 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 4 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 3 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 2 generations backK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
- 1 generation backK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012
- This deviceK160454 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −10 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −9 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −8 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −7 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −6 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −5 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −4 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| −3 | K031623 | Modification to Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 4 |
| −2 | K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip… | AtriCure, Inc. | 2010 | — |
| −1 | K122276 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | 2012 | — |
| 0 (this device) | K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
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 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122276 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipSummary page 4…lass II Product Code: FZP III. Predicate Device The device proposed for modification in this submission is the AtriClip LAA Exclusion System cleared via K122276 on August 29, 2012. The predicate device has not been subject to a design-related recall. The following reference devices were… | 2012 |
| † | K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove… | 2010 |
| † | K131107 | Atriclip Gillinov-Cosgrove Laa Clip | 2013 |
| † | K142120 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip | 2014 |
| † | K150996 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | 2015 |
| † | K153500 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 30, 2016 | Class II | Z-1148-2017 | Component design/selection | A complaint of the PRO2 jaw breaking prior to surgery being performed. |
| Sep 22, 2016 | Class II | Z-0377-2017 | Device Design | There is a potential for a component failure of the device which could necessitate medical intervention. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 12 of the 66 ancestors have a recall of any class.
- 4 other devices also cite its predicate K122276.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FZP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FZP
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FZP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZP
1,902in 2025
MAUDE reports naming product code FZP, 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 | 6 | 31 | 1 | 1,877 |
| 2008 | 4 | 23 | 6 | 981 |
| 2009 | 3 | 22 | 0 | 2,160 |
| 2010 | 6 | 47 | 1 | 2,367 |
| 2011 | 3 | 124 | 0 | 1,678 |
| 2012 | 2 | — | 1 | 1,677 |
| 2013 | 3 | 47 | 0 | 2,381 |
| 2014 | 3 | 29 | 1 | 2,320 |
| 2015 | 8 | 182 | 0 | 2,871 |
| 2016 | 5 | 72 | 2 | 1,840 |
| 2017 | 4 | 29 | 1 | 2,594 |
| 2018 | 4 | 143 | 0 | 2,718 |
| 2019 | 1 | — | 3 | 2,903 |
| 2020 | 2 | — | 1 | 1,760 |
| 2021 | 0 | — | 0 | 1,759 |
| 2022 | 3 | 227 | 0 | 1,575 |
| 2023 | 3 | 65 | 0 | 1,918 |
| 2024 | 2 | — | 0 | 2,067 |
| 2025 | 5 | 90 | 0 | 1,902 |
| 2026 | 2 | — | 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.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160454 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160454: 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/K160454
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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