# K984355: Point Setter

- Pathway: 510(k) (Traditional)
- Applicant: Mitaka USA, Inc.
- Decided: Apr 1, 1999 after 115 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

## Recalls of this device
- Feb 27, 2009 · Not classified · Z-1539-2012: Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.

## Indications for use
The point setter is indicated for use as a holder for an endoscope.

Source page: https://510kreport.com/device/K984355
Methodology: https://510kreport.com/methodology