# K260565: SmartClip Delivery Catheter (ADR-1715)

- Pathway: 510(k) (Traditional)
- Applicant: Elucent Medical
- Decided: May 14, 2026 after 84 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931154 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142934: CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved, Covidien (2015) Summary page 5.

## Indications for use
SmartClip Delivery Catheter is to be utilized through a flexible bronchoscope by physicians trained in endoscopic techniques to puncture the tracheobronchial wall and to facilitate the delivery and placement of an Elucent SmartClip soft tissue marker within the lung parenchyma at a target site. The device is used in situations where the lung tissue site needs to be marked for future diagnostic or therapeutic procedures.

Source page: https://510kreport.com/device/K260565
Methodology: https://510kreport.com/methodology