# K991989: Mitaka Point Setter

- Pathway: 510(k) (Traditional)
- Applicant: Mitaka USA, Inc.
- Decided: Aug 27, 1999 after 74 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K090792: Mitaka Uniarm (2009), 0 descendants of its own
- K043128: Olympus Endoarm (2004), 0 descendants of its own

## Indications for use
This instrument is intended for use by qualified surgeons for holding rigid and flexible endoscopes during diagnostic and therapeutic neurologic procedures.

Source page: https://510kreport.com/device/K991989
Methodology: https://510kreport.com/methodology