# K232405: Endofix Exo

- Pathway: 510(k) (Traditional)
- Applicant: Aktormed GmbH
- Decided: Apr 25, 2024 after 259 days
- Product code: OCV (Endoscope Holder)
- 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: 5 generations back to K945572 (1995). 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)
- K190576: WalterLorenz Surgical Assist Arm Scope Holder, Biomet Microfixation (2019) Summary page 5.

## Indications for use
The ENDOFIX EXO is indicated for use in interventions where a rigid endoscope / exoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K232405
Methodology: https://510kreport.com/methodology