# K061292: Statarius, Model 001 003

- Pathway: 510(k) (Traditional)
- Applicant: Kinetic Surgical, LLC
- Decided: Jul 3, 2006 after 55 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 K945572 (1995). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050051: Armand Endoscope Holder, KLS-Martin L.P. (2005) Summary page 1.

## Most influential descendants
- K093616: V. Mueller Camera Controller with Storage Cart (2009), 1 descendant of its own
- K102179: Enview (TM) (2010), 0 descendants of its own

## Indications for use
The Statarius T M is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 5-12mm during diagnostic and therapeutic surgical procedures.

Source page: https://510kreport.com/device/K061292
Methodology: https://510kreport.com/methodology