# K254231: Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Surgical Corporation
- Decided: Jul 20, 2026 after 203 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K021808 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230480: Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML), Teleflex Medical (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K254231
Methodology: https://510kreport.com/methodology