510(k) · Cleared
ClearedLaparoscopic Compression Anastomosis Clip (Lapcac)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Niti Medical Technologies, Ltd. · FZP Clip, Implantable
Cleared on Dec 1, 2004 as substantially equivalent to K033324 (Niti Medical Technologies, Ltd., 2004) and 3 other predicates after a 21-day review. Its family tree reaches back 10 generations to 1993. 5 later devices descend from it.
- Decided
- Dec 1, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K933887 (1993). 37 ancestors in all, the oldest K771412 (1977). 5 later devices descend from it, 2 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 backK033324 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 1 generation backK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- This deviceK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK050356 Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK250541 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK062008 Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK253550 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK093661 ColonringNiti Surgical Solutions, Ltd. · 2011
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 backK033324 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 1 generation backK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- This deviceK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
Most influential descendants
Showing 5 of 5 · See all- K050356Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2005 · cites it directly2descendants
- K250541Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2025 · cites it directly1descendant
- K062008Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2006 · 2 generations on1descendant
- K253550Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2026 · 2 generations on0descendants
- K093661ColonringNiti Surgical Solutions, Ltd. · 2011 · 2 generations on0descendants
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 | K033324 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| −1 | K041751 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| 0 (this device) | K043115 | Laparoscopic Compression Anastomosis Clip (Lapcac) | Niti Medical Technologies, Ltd. | 2004 | — |
| +1 | K050356 | Compression Anastomosis Ring (Car) | Niti Medical Technologies, Ltd. | 2005 | — |
| +1 | K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2025 | — |
| +2 | K062008 | Endo Car Compression Anastomosis Ring (Car) | Niti Medical Technologies, Ltd. | 2006 | — |
| +2 | K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2026 | — |
| +2 | K093661 | Colonring | Niti Surgical Solutions, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K033324 | Compression Anastomosis Clip (Cac)Summary page 2…by the Division of General and Restorative Devices. Predicate Device: * CAC, Compression Anastomosis Clip (NiTi Medical Technologies Ltd.) cleared under K033324. • CAC, Compression Anastomosis Clip (NiTi Medical Technologies Ltd.) cleared under K041751. * Endo GIA Unive… | 2004 |
| * | K041751 | Compression Anastomosis Clip (Cac)Summary page 2…omosis Clip (NiTi Medical Technologies Ltd.) cleared under K033324. • CAC, Compression Anastomosis Clip (NiTi Medical Technologies Ltd.) cleared under K041751. * Endo GIA Universal Stapler System (United States Surgical Cooperation, USA) originally cleared under K892233 and… | 2004 |
| * | K892233 | Auto Suture (R) Endoscopic Gia (TM) Surgical StaplerSummary page 2…ical Technologies Ltd.) cleared under K041751. * Endo GIA Universal Stapler System (United States Surgical Cooperation, USA) originally cleared under K892233 and K913802. Performance Standards: No performance standards have been established for such device under Section 514… | 1989 |
| * | K913802 | Auto Suture (R) Powered Endoscopic Gia (TM) StaplerSummary page 2…ogies Ltd.) cleared under K041751. * Endo GIA Universal Stapler System (United States Surgical Cooperation, USA) originally cleared under K892233 and K913802. Performance Standards: No performance standards have been established for such device under Section 514 of the Fede… | 1991 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 5 of the 37 ancestors have a recall of any class.
- Of its descendants, K050356 (Niti Medical Technologies, Ltd., 2005) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K033324.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) is intended to be used to facilitate side-to-side anastomosis of the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi Clip is passed from the body. The LapCAC is indicated for open, minimally invasive or laparoscopic procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043115: Laparoscopic Compression Anastomosis Clip (Lapcac).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043115
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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