# K090792: Mitaka Uniarm

- Pathway: 510(k) (Traditional)
- Applicant: Mitaka Kohki Co., Ltd.
- Decided: Jul 6, 2009 after 104 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: 3 generations back to K951854 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984355: Point Setter, Mitaka USA, Inc. (1999) Summary page 1.
- K991989: Mitaka Point Setter, Mitaka USA, Inc. (1999) Summary page 1.
- K000663: Kronner Low Profile Scope Holder, Kronner Prototypes, Inc. (2000) Summary page 1.
- K973543: Kronner Low Profile Scope Holder, Kronner Prototypes, Inc. (1998) Summary page 1.

## Indications for use
The UniARM is for use in holding medical devices such as endoscopes and retractors in surgery.

Source page: https://510kreport.com/device/K090792
Methodology: https://510kreport.com/methodology