# K260183: MediBot Needle Driver Uno

- Pathway: 510(k) (Traditional)
- Applicant: Parallel Robotics, LLC
- Decided: May 24, 2026 after 123 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: 5 generations back to K912544 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173919: HX Device, Human Extension, Ltd. (2018) Summary page 5.

## Indications for use
The MediBot Needle Driver Uno medical device is intended to assist in accurate control of its needle holder instrument for endoscopic suturing during laparoscopic or abdominal minimally invasive surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions For Use.

Source page: https://510kreport.com/device/K260183
Methodology: https://510kreport.com/methodology