# K032238: Twister Superelastic Ligating Clip and Applier

- Pathway: 510(k) (Traditional)
- Applicant: Neurosel (Medical) Limited
- Decided: Sep 9, 2003 after 50 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: 1 generation back to K830503 (1983). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830503: Ligaclip Titanium Ligating Clip, ETHICON, Inc. (1983) Summary page 1.
- K864102: Ligaclip 20/20* Multiple Clip Applier, ETHICON, Inc. (1986) Summary page 1.

## Most influential descendants
- K140932: Amsel Occluder Device (2015), 2 descendants of its own
- K260677: Vessel Closure Device (VCD177213P) (2026), 0 descendants of its own
- K180650: Amsel Endo Occluder (2018), 0 descendants of its own

## Indications for use
The TwisterTM Superelastic Ligating Clip, Size M and its applier is intended for the permanent occlusion or ligation of blood vessels and other tubular body structures, wherever a metal ligating clip is indicated, and within the size range of 2.0 to 3.5mm diameter.

Source page: https://510kreport.com/device/K032238
Methodology: https://510kreport.com/methodology