510(k) · Cleared
ClearedImplantable Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · FZP Clip, Implantable
Cleared on Jul 30, 1997 after a 148-day review. The FDA summary names its predicate without a number. 57 later devices descend from it.
- Decided
- Jul 30, 1997
- Review
- 148 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 0
57 later devices descend from it, 5 citing it directly.
- This deviceK970793 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1997
- Descendant · cites it directly · 49 of its ownK003446 Symmetry Aortic Clip SystemSt. Jude Medical Cardiovascular Group, Inc. · 2001
- Descendant · 2 generations on · 44 of its ownK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- Descendant · 3 generations on · 43 of its ownK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- Descendant · 3 generations on · 42 of its ownK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- Descendant · 3 generations on · 41 of its ownK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K003446Symmetry Aortic Clip SystemSt. Jude Medical Cardiovascular Group, Inc. · 2001 · cites it directly49descendants
- K013664Coalescent Surgical U-ClipCoalescent Surgical · 2002 · 2 generations on44descendants
- K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002 · 3 generations on43descendants
- K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002 · 3 generations on42descendants
- K024366Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · 3 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970793 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| +1 | K003446 | Symmetry Aortic Clip System | St. Jude Medical Cardiovascular Group, Inc. | 2001 | — |
| +2 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| +3 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| +3 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| +3 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | — | AUTO SUTURE* Vascular Anastomosis** clip cartridge Named without a submission number |
What descends from it? (57)
See all 575 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K003446 | Symmetry Aortic Clip System | 2001 | 49 |
| K011589 | Corlink Aad (3.5 to 6.0 M M Outer Diameter Vessels),Model 200-064, Corlink Aad (2.0 to… | 2001 | 2 |
| K013683 | Modification to: Abbott Vascular Suture Anastomosis Device | 2001 | 1 |
| K030926 | Fast Throw Stainless Steel Surgical Suture | 2003 | 0 |
| K984438 | Modified Auto Suture*VCS** Anastomotic**Clip Cartridge | 1999 | 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?
- Of its descendants, K003446 (St. Jude Medical Cardiovascular Group, Inc., 2001) has gone furthest, with 49 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.
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 AUTO SUTURE* VCS* Anastomotic** clip cartridge is intended to apply titanium clips for use in the creation of vascular anastomoses and in the attachment of synthetic vascular prosthesis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970793 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970793: Implantable Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970793
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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