# K960878: Mahler Abdominal Wall Elevator

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Mar 15, 1996 after 11 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K943614 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943614: A.W.E.L., Medi-Flex (1995) Summary page 1.

## Indications for use
The Maher Abdominal Wall Elevator is used to elevate/retract the abdominal wall for low pressure laparoscopic procedures. The device is intended to be used after the establishment of a pneumoperitoneum.

Source page: https://510kreport.com/device/K960878
Methodology: https://510kreport.com/methodology