# K233700: Avicenna Roboflex

- Pathway: 510(k) (Traditional)
- Applicant: Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi
- Decided: Aug 16, 2024 after 273 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- 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
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
- K253505: Zamenix™ P (2026), 0 descendants of its own

## Indications for use
Avicenna Roboflex is indicated for endoscopic examination in the urinary tract with transurethral access and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K233700
Methodology: https://510kreport.com/methodology