510(k) · Cleared
ClearedAtriClip FLEX-V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AtriCure, Inc. · FZP Clip, Implantable
Cleared on Jan 31, 2018 as substantially equivalent to K173031 (AtriCure, Inc., 2017) after a 29-day review. Its family tree reaches back 13 generations to 1993. 8 later devices descend from it.
- Decided
- Jan 31, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K933887 (1993). 68 ancestors in all, the oldest K771412 (1977). 8 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 9 generations between
- 3 generations backK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012
- 2 generations backK153500 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V…AtriCure, Inc. · 2016
- 1 generation backK173031 AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017
- This deviceK180010 AtriClip FLEX-VAtriCure, Inc. · 2018
- Descendant · cites it directly · 7 of its ownK181474 ArtiClip LAA Exclusion SystemAtriCure, Inc. · 2018
- Descendant · 2 generations on · 6 of its ownK191413 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2019
- Descendant · 3 generations on · 5 of its ownK210293 AtriClip LAA Exclusion SystemAtriCure, Inc. · 2021
- Descendant · 4 generations on · 2 of its ownK220305 Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon · 2022
- Descendant · 4 generations on · 1 of its ownK233407 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2023
Show all 13 generations
- Root · 13 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 12 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 11 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 10 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 9 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 8 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 7 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 6 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 5 generations backK031623 Modification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 4 generations backK093679 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip…AtriCure, Inc. · 2010
- 3 generations backK122276 Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc. · 2012
- 2 generations backK153500 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V…AtriCure, Inc. · 2016
- 1 generation backK173031 AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. · 2017
- This deviceK180010 AtriClip FLEX-VAtriCure, Inc. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K181474ArtiClip LAA Exclusion SystemAtriCure, Inc. · 2018 · cites it directly7descendants
- K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc. · 2019 · 2 generations on6descendants
- K210293AtriClip LAA Exclusion SystemAtriCure, Inc. · 2021 · 3 generations on5descendants
- K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon · 2022 · 4 generations on2descendants
- K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −12 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −11 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −10 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −9 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −8 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −7 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −6 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| −5 | K031623 | Modification to Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 4 |
| −4 | K093679 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip… | AtriCure, Inc. | 2010 | — |
| −3 | K122276 | Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip | AtriCure, Inc. | 2012 | — |
| −2 | K153500 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip | AtriCure, Inc. | 2016 | — |
| −1 | K173031 | AtriClip LAA Exclusion System with Preloaded PRO·V Clip | AtriCure, Inc. | 2017 | — |
| 0 (this device) | K180010 | AtriClip FLEX-V | AtriCure, Inc. | 2018 | — |
| +1 | K181474 | ArtiClip LAA Exclusion System | AtriCure, Inc. | 2018 | — |
| +2 | K191413 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip… | AtriCure, Inc. | 2019 | — |
| +3 | K210293 | AtriClip LAA Exclusion System | AtriCure, Inc. | 2021 | — |
| +4 | K220305 | Syntheon LAA Exclusion System, Syntheon LAA Selection Guide | Syntheon | 2022 | — |
| +4 | K233407 | AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0)… | AtriCure, Inc. | 2023 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K173031 | AtriClip LAA Exclusion System with Preloaded PRO·V ClipSummary page 4…sification Panel: General and Plastic Surgery Predicate Device: AtriClip LAA Exclusion System with Preloaded PRO·V Clip (K173031, FZP, October 25, 2017) III. Device Description The AtriClip FLEX∙V device consists of a single use, sterile, self-closing,… | 2017 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181474 | ArtiClip LAA Exclusion System | 2018 | 7 |
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 25 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 12 of the 68 ancestors have a recall of any class.
- Of its descendants, K181474 (AtriCure, Inc., 2018) has gone furthest, with 7 descendants of its own.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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/K180010 · printed Nov 3, 2026
Cite this page
510(k) Report. “K180010: AtriClip FLEX-V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K180010
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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