510(k) · Cleared
ClearedInno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiwan Surgical Corporation · FZP Clip, Implantable
Cleared on Jul 20, 2026 as substantially equivalent to K230480 (Teleflex Medical, 2023) after a 203-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Jul 20, 2026
- Review
- 203 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K021808 (2002). No later device cites it as a predicate yet.
- Root · 4 generations backK021808 Weck Hem-O-Lok Automatic Ligating Clip ApplierWeck · 2002 · Recalled
- 3 generations backK142777 Weck Hem-o-lok Auto Endo5 Ligating Clip ApplierTeleflexmedical, Inc. · 2014 · Recalled
- 2 generations backK152081 Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierTeleflexmedical, Inc. · 2015 · Recalled
- 1 generation backK230480 Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Teleflex Medical · 2023
- This deviceK254231 Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™…Taiwan Surgical Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021808 | Weck Hem-O-Lok Automatic Ligating Clip Applier | Weck | 2002 | 7 |
| −3 | K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip Applier | Teleflexmedical, Inc. | 2014 | 1 |
| −2 | K152081 | Weck Auto Endo5 Hem-o-lok Ligating Clip Applier | Teleflexmedical, Inc. | 2015 | 1 |
| −1 | K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | Teleflex Medical | 2023 | — |
| 0 (this device) | K254231 | Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating… | Taiwan Surgical Corporation | 2026 | — |
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 |
|---|---|---|---|
| * | K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Summary page 5…ble Classification Name: 878.4300 Classification Product Code: FZP, GDO Device Class: II Predicate Device K230480, Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (Primary)… | 2023 |
| † | K133202 | Hem-O-Lok Ligating Clip | 2013 |
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 4 companies; a new generation was cleared every 7.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K230480.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Inno-Hook™ ligating clips are non-absorbable polymer clips indicated for ligation of vessels or tissue structures.
The Inno-Hook™ Disposable Clip Applier (Ligating Clips) is indicated as the delivery device for the Inno-Hook™ ligating clips. These clip appliers are designed for use with 5mm and 10mm cannulas. 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/K254231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254231: Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254231
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026