510(k) · Cleared
ClearedVas-Q-Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanova Biomaterials, Inc. · FZP Clip, Implantable
Cleared on Mar 25, 2016 as substantially equivalent to K993157 (Weck Closure Systems, 1999) after a 255-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Mar 25, 2016
- Review
- 255 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922186 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK922186 Hem-O-Lok -- ModificationLinvatec Corp. · 1992
- 2 generations backK982941 Hem-O-Lok Model Numbers 523900, 523970Weck Closure Systems · 1998 · Recalled
- 1 generation backK993157 Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer…Weck Closure Systems · 1999 · Recalled
- This deviceK151943 Vas-Q-ClipNanova Biomaterials, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922186 | Hem-O-Lok -- Modification | Linvatec Corp. | 1992 | — |
| −2 | K982941 | Hem-O-Lok Model Numbers 523900, 523970 | Weck Closure Systems | 1998 | 1 |
| −1 | K993157 | Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model… | Weck Closure Systems | 1999 | 1 |
| 0 (this device) | K151943 | Vas-Q-Clip | Nanova Biomaterials, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K993157 | Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model 544240Summary page 4…vice Class: Class II 9) Predicated Devices: Vas-Q-ClipTM is believed to be substantially equivalent to Hem-O-lok® Ligating Clip (K993157). 10) Indication for Use: Vas-Q-ClipTM ligating clips are intended for use in procedures involving ligation of ves… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 6.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 3 other devices also cite its predicate K993157.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Vas-Q-Clip”"TM ligating clips are intended for use in procedures involving ligation of vessels or tissue structures.
Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
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/K151943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151943: Vas-Q-Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151943
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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