# K052745: Assisto Arm Systems

- Pathway: 510(k) (Traditional)
- Applicant: Geomed Medizin-Technik GmbH & Co.
- Decided: Nov 23, 2005 after 54 days
- Product code: GWG (Endoscope, Neurological)
- Device class: 2
- Regulation: 21 CFR 882.1480
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945572 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K992006: Neuroview Instrument Holder, Model 300-33, Integra Neurocare, LLC (1999) Summary page 1.
- K950214: Abdominal Wall Retractor, Omni-Tract Surgical, Div. Minn. Scientific, Inc. (1995) Summary page 1.

## Recalls of this device
- Dec 16, 2011 · Not classified · Z-1061-2012: The product may fracture during surgical procedures.

## Indications for use
ASSISTO® Arm Systems consist of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 2.7mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.

Source page: https://510kreport.com/device/K052745
Methodology: https://510kreport.com/methodology