# K152598: Endo Keeper

- Pathway: 510(k) (Traditional)
- Applicant: Nelis
- Decided: Mar 17, 2016 after 188 days
- Product code: OTJ (Laparoscopic Single Port Access Device)
- 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: 7 generations back to K940232 (1994). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141715: Glove Port, Nelis (2015) Summary page 4.

## Indications for use
The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. This device is single use and sterilized.

Source page: https://510kreport.com/device/K152598
Methodology: https://510kreport.com/methodology