# K232062: Uni-port

- Pathway: 510(k) (Traditional)
- Applicant: Dalim Medical Corp.
- Decided: Jan 16, 2024 after 189 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K141715: Glove Port, Nelis (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Uni-port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

Source page: https://510kreport.com/device/K232062
Methodology: https://510kreport.com/methodology