510(k) · Cleared
Recalled · Class II · 2023Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting Clips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · FZP Clip, Implantable
Cleared on Nov 27, 2013 as substantially equivalent to K982313 (Weck Closure Systems, 1998) and 1 other predicate after a 93-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 27, 2013
- Review
- 93 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K841547 (1984). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K192711Dannik Titanium Ligation ClipDannik · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841547 | Hemoclip Ligating Clips Med/SML | Edward Weck, Inc. | 1984 | — |
| 0 (this device) | K132658 | Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon… | Teleflex Medical | 2013 | — |
| +1 | K192711 | Dannik Titanium Ligation Clip | Dannik | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K982313 | Horizon Titanium Clips, Horizon Tantalum ClipsSummary page 2…510(k) No. Date Cleared Horizon Tm Ligating Clip ______________________(Weck) Teleflex Medical* K982313 08/10/1998 Hemoclip@ Traditional Ligating Teleflex Medical K841547 08/14/1984 Clip… | 1998 |
| * | K841547 | Hemoclip Ligating Clips Med/SMLSummary page 2…___(Weck) Teleflex Medical* K982313 08/10/1998 Hemoclip@ Traditional Ligating Teleflex Medical K841547 08/14/1984 Clip (Weck) J. Comparison To Predicate Devices The proposed… | 1984 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192711 | Dannik Titanium Ligation Clip | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2023 | Class II | Z-1663-2023 | Under Investigation by firm | Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on… |
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. 2013, 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?
Weck® Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size, type and material of the clip based upon their experience, judgment and needs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132658: Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132658
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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