510(k) · Cleared
Recalled · Class II · 2017Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · FZP Clip, Implantable
Cleared on Aug 26, 2015 as substantially equivalent to K142777 (Teleflexmedical, Inc., 2014) after a 30-day review. Its family tree reaches back 2 generations to 2002. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 26, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021808 (2002). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK021808 Weck Hem-O-Lok Automatic Ligating Clip ApplierWeck · 2002 · Recalled
- 1 generation backK142777 Weck Hem-o-lok Auto Endo5 Ligating Clip ApplierTeleflexmedical, Inc. · 2014 · Recalled
- This deviceK152081 Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierTeleflexmedical, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK230480 Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Teleflex Medical · 2023
- Descendant · 2 generations on · 0 of its ownK254231 Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™…Taiwan Surgical Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK250643 Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK161758 Weck Auto Endo10 Automatic Endoscopic Clip ApplierTeleflex Medical · 2016
Most influential descendants
Showing 4 of 4 · See all- K230480Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Teleflex Medical · 2023 · cites it directly2descendants
- K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation · 2026 · 2 generations on0descendants
- K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025 · 2 generations on0descendants
- K161758Weck Auto Endo10 Automatic Endoscopic Clip ApplierTeleflex Medical · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021808 | Weck Hem-O-Lok Automatic Ligating Clip Applier | Weck | 2002 | 7 |
| −1 | K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip Applier | Teleflexmedical, Inc. | 2014 | 1 |
| 0 (this device) | K152081 | Weck Auto Endo5 Hem-o-lok Ligating Clip Applier | Teleflexmedical, Inc. | 2015 | — |
| +1 | K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | Teleflex Medical | 2023 | — |
| +2 | K254231 | Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating… | Taiwan Surgical Corporation | 2026 | — |
| +2 | K250643 | Disposable Polymer Ligation Clips | Hangzhou Kangji Medical Instrument Co., Ltd. | 2025 | — |
| +1 | K161758 | Weck Auto Endo10 Automatic Endoscopic Clip Applier | Teleflex Medical | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip ApplierSummary page 5…Device Manufacturer 510(k) No. Date Cleared Weck Auto Endo5 Hem-o-lok Teleflex Medical K142777 12/19/2014 Ligating Clip Applier J. Comparison To Predicate Devices The proposed Auto Endo5 5mm Automatic E… | 2014 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2017 | Class II | Z-0083-2018 | Under Investigation by firm | The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 12.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K230480 (Teleflex Medical, 2023) has gone furthest, with 2 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. 2015, 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 Auto Endo5 Hem-o-Jok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-Jok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas.
Hem-o-lok 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 so 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/K152081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152081: Weck Auto Endo5 Hem-o-lok Ligating 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/K152081
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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