# K152618: PANTHER Cutter Stapler

- Pathway: 510(k) (Traditional)
- Applicant: B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
- Decided: Nov 12, 2015 after 59 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- 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 K843034 (1984). 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)
- K091322: Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40G, Ethicon Endo-Surgery, Inc. (2009) Summary page 4.

## Indications for use
The PANTHER Cutter Stapler is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.

Source page: https://510kreport.com/device/K152618
Methodology: https://510kreport.com/methodology