510(k) · Cleared
Recalled · Class II · 2016Auto Suture Modified VCS Clip Applier
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 Sep 23, 1996 as substantially equivalent to K933887 (United States Surgical, A Division of Tyco Healthc, 1993) after a 118-day review. Its family tree reaches back 1 generation to 1993. 58 later devices descend from it. It has been recalled 7 times.
- Decided
- Sep 23, 1996
- Review
- 118 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933887 (1993). 58 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- This deviceK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996
- Descendant · cites it directly · 55 of its ownK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- Descendant · 2 generations on · 52 of its ownK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- Descendant · 3 generations on · 44 of its ownK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- Descendant · 4 generations on · 43 of its ownK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- Descendant · 2 generations on · 42 of its ownK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K994160Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000 · cites it directly55descendants
- K012317Coalescent Surgical U-ClipCoalescent Surgical · 2001 · 2 generations on52descendants
- K013664Coalescent Surgical U-ClipCoalescent Surgical · 2002 · 3 generations on44descendants
- K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002 · 4 generations on43descendants
- K023125Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002 · 2 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| 0 (this device) | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | — |
| +1 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| +2 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| +3 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| +4 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| +2 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K933887 | Implantable ClipSummary page 1…ied VCS* Clip** device is identical in safety and effectiveness to its currently marketed predicate - U.S. Surgical Corp.'s Vascular Anastomosis Clip** applier - 510(k) #K933887. This clip applier has been marketed for the closure of arteriotomics and venotomies, the attachment of synthetic vascular prosth… | 1993 |
What descends from it? (58)
See all 584 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2016 | Class II | Z-2289-2016 | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. |
| Jun 22, 2016 | Class II | Z-2284-2016 | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. |
| Jun 22, 2016 | Class II | Z-2283-2016 | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use |
| Jun 22, 2016 | Class II | Z-2286-2016 | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. |
| Jun 22, 2016 | Class II | Z-2285-2016 | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. |
| Jun 22, 2016 | Class II | Z-2287-2016 | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. |
| Jun 22, 2016 | Class II | Z-2288-2016 | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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* Modified VCS* Clip #* Applier is available in multiple sizes and has application in the closure of arteriotomies and venotomies, the attachment of synthetic vascular prosthesis, the creation of everting anastomosis in blood vessels and other small tubular structures, and for the approximation of prosthetic grafts and dural tissue.
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/K962043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962043: Auto Suture Modified VCS Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962043
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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