# K253505: Zamenix™ P

- Pathway: 510(k) (Traditional)
- Applicant: Roen Surgical, Inc.
- Decided: Aug 7, 2026 after 280 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
Longest line of descent: 1 generation back to K233700 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233700: Avicenna Roboflex, Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi (2024) Summary page 5.

## Indications for use
Zamenix™ P 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. The device is intended for use in patients aged 22 or older.

Source page: https://510kreport.com/device/K253505
Methodology: https://510kreport.com/methodology