# K043128: Olympus Endoarm

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corporation
- Decided: Dec 21, 2004 after 39 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
Longest line of descent: 2 generations back to K923555 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971340: Olympus Neuro Endoscope, Olympus Optical, Co. (1998) Summary page 2.
- K982133: Olympus Endoscopic System Lumbar Hernia Discectomy and Its Ancillary Equipment, The Olympus Optical Co. (1998) Summary page 2.
- K991989: Mitaka Point Setter, Mitaka USA, Inc. (1999) Summary page 2.

## Indications for use
The EndoArm system consists of the EndoAmm, a stabilizing fixation(adapter), Neuroendoscope (A1***A series). A number of components and accessories are also necessary for this system. EndoArm This product has been designed for manipulation and positioning of the Neuroendoscope during Neurosurgery and spinesurgery. Neuroendoscopes (AB1000A, AB1001A, A81002A, A81010A, AB1011A, AB1012A, AB1031A, AB1032A, AB1041A, A81042A) The Neuroendoscopes are intended for use in observation and diagnosis of the brain ventricles and brain parenchyma, such as observation and diagnosis of cerebral aneurysms, hypophysis tumors, hematomas, brain tumors, cerebral vascular systems, cranial nerve and vascular compression syndromes as well as intended for use in observation and diagnosis of the lumber and cervical spine, such as hemiated disc material, nerve roots and nucleus material.

Source page: https://510kreport.com/device/K043128
Methodology: https://510kreport.com/methodology