510(k) · Cleared
Recalled · Class II · 2016Weck Hem-o-lok Auto Endo5 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 Dec 19, 2014 as substantially equivalent to K021808 (Weck, 2002) after an 84-day review. Its family tree reaches back 1 generation to 2002. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 19, 2014
- Review
- 84 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021808 (2002). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK021808 Weck Hem-O-Lok Automatic Ligating Clip ApplierWeck · 2002 · Recalled
- This deviceK142777 Weck Hem-o-lok Auto Endo5 Ligating Clip ApplierTeleflexmedical, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK152081 Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierTeleflexmedical, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 2 of its ownK230480 Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Teleflex Medical · 2023
- Descendant · 3 generations on · 0 of its ownK254231 Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™…Taiwan Surgical Corporation · 2026
- Descendant · 3 generations on · 0 of its ownK250643 Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK161758 Weck Auto Endo10 Automatic Endoscopic Clip ApplierTeleflex Medical · 2016
Most influential descendants
Showing 5 of 5 · See all- K152081Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierTeleflexmedical, Inc. · 2015 · cites it directly4descendants
- K230480Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Teleflex Medical · 2023 · 2 generations on2descendants
- K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation · 2026 · 3 generations on0descendants
- K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd. · 2025 · 3 generations on0descendants
- K161758Weck Auto Endo10 Automatic Endoscopic Clip ApplierTeleflex Medical · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021808 | Weck Hem-O-Lok Automatic Ligating Clip Applier | Weck | 2002 | 7 |
| 0 (this device) | K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip Applier | Teleflexmedical, Inc. | 2014 | — |
| +1 | K152081 | Weck Auto Endo5 Hem-o-lok Ligating Clip Applier | Teleflexmedical, Inc. | 2015 | 1 |
| +2 | K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | Teleflex Medical | 2023 | — |
| +3 | K254231 | Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating… | Taiwan Surgical Corporation | 2026 | — |
| +3 | K250643 | Disposable Polymer Ligation Clips | Hangzhou Kangji Medical Instrument Co., Ltd. | 2025 | — |
| +2 | K161758 | Weck Auto Endo10 Automatic Endoscopic Clip Applier | Teleflex Medical | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K021808 | Weck Hem-O-Lok Automatic Ligating Clip ApplierSummary page 5…anufacturer 510(k) No. Date Cleared Weck Hem-o-lok Automatic Teleflex Medical K021808 8/14/2002 Ligating Clip Applier (Weck Closure) J. Comparison To Predicate Devices The proposed W… | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152081 | Weck Auto Endo5 Hem-o-lok Ligating Clip Applier | 2015 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2016 | Class II | Z-0886-2016 | Nonconforming Material/Component | The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application. |
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. 2014, 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?
The Weck Auto Endo5 Hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok 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 as stated in the FDA summary.
https://510kreport.com/device/K142777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142777: Weck Hem-o-lok Auto Endo5 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/K142777
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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