# K180650: Amsel Endo Occluder

- Pathway: 510(k) (Traditional)
- Applicant: Amsel Medical Corporation
- Decided: Nov 15, 2018 after 247 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: 3 generations back to K830503 (1983). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050344: Ligaclip 5 M/L MM Endoscopic Multiple Clip Applier, Ethicon Endo Surgery, Inc. (2005) Summary page 5.
- K140932: Amsel Occluder Device, Amsel Medical Corporation (2015). Our reading of the summary gave K149032, which is not a number in FDA’s lists. Corrected to the only number with two digits swapped that is an earlier device of this one’s maker, Amsel Medical Corporation, in this field.

## Indications for use
Amsel Endo Occluder device is an endoscopic ligating clip applier and clips, which is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

Source page: https://510kreport.com/device/K180650
Methodology: https://510kreport.com/methodology