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destino reach
Oscor
Summary: The destino reach by Oscor is a steerable guiding sheath used primarily in endobronchial procedures. Key evidence highlights its role in enhanced navigation during lung biopsies.
FDA Clearance Information
Pathway
510K
Number
K151951 ↗
Decision Date
September 22, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The destino reach received FDA clearance through the 510(k) pathway on September 22, 2015. It is manufactured by Oscor and classified as a Class 2 device under product code DYB.
What It Is
The destino reach is a steerable guiding sheath designed for endobronchial navigation. It facilitates precise targeting in procedures such as lung biopsies, utilizing advanced imaging techniques.
Clinical Applications
Commonly used in endobronchial procedures, the destino reach aids in navigating complex bronchial pathways, particularly in lung biopsy cases where precise targeting is crucial.
Evidence Summary
The literature includes three studies, with types ranging from retrospective to other designs, spanning publication years from 2007 to 2025. These studies explore the device's application in clinical settings.
Reported Outcomes
Published studies report that the destino reach enhances navigation accuracy in endobronchial procedures. It has been shown to improve targeting precision during lung biopsies, contributing to better diagnostic outcomes.
Safety Profile
Reported complications include potential navigation challenges in complex bronchial anatomy. However, specific adverse events related to the device itself were not detailed in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for destino reach?
The destino reach is indicated for use in endobronchial procedures, particularly for enhancing navigation during lung biopsies.
What outcomes have been reported in clinical studies?
Studies report improved navigation and targeting precision in lung biopsies using the destino reach.
What complications have been reported?
Reported complications include navigation challenges in complex bronchial anatomy, though specific adverse events were not detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.