510(k) · Cleared
ClearedAtriClip PRO, PRO2, and PRO V LAA Exclusion System devices 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 May 19, 2017 as substantially equivalent to K093679 (AtriCure, Inc., 2010) after a 179-day review. Its family tree reaches back 10 generations to 1993. 1 later device descends from it.
- Decided
- May 19, 2017
- Review
- 179 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). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 6 generations between
- 3 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 2 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 1 generation backK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
- This deviceK163261 AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with…AtriCure, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK172742 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2017
Show all 10 generations
- Root · 10 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 9 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 8 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 7 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 6 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 5 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 4 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 3 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 2 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 1 generation backK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
- This deviceK163261 AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with…AtriCure, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −9 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −8 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −7 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −6 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −5 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −4 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −3 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| −2 | K031623 | Modification to Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 4 |
| −1 | K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip… | AtriCure, Inc. | 2010 | — |
| 0 (this device) | K163261 | AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded… | AtriCure, Inc. | 2017 | — |
| +1 | K172742 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) | AtriCure, Inc. | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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 |
|---|---|---|---|
| * | K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…Summary page 4…ion Name: Implantable Clip and Clip Applier (21 CFR 878.4300) Regulatory Class: Class II Product Code: FZP III. Predicate Device Predicate Device: K093679 AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip The following reference devices were also used in thi… | 2010 |
| † | K122276 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip | 2012 |
| † | 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 |
| † | K160454 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172742 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) | 2017 | 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?
- The line of descent spans 24 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, K172742 (AtriCure, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K093679.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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, performed under direct visualization and in conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163261: AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163261
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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