Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

XENX STONE MANAGEMENT DEVICE

K-Number: K123438 · 2013-01-10

ApplicantXenolith Medical
Decision Date2013-01-10
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

XENX STONE MANAGEMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Xenolith Medical. It received FDA 510(k) clearance on 2013-01-10 under 510(k) number K123438. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XENX STONE MANAGEMENT DEVICE?

XENX STONE MANAGEMENT DEVICE is a medical device that received FDA 510(k) clearance on 2013-01-10. The listed applicant is Xenolith Medical. The 510(k) number is K123438.

When did XENX STONE MANAGEMENT DEVICE receive FDA 510(k) clearance?

XENX STONE MANAGEMENT DEVICE received FDA 510(k) clearance on 2013-01-10, under 510(k) number K123438.

Who is the listed applicant for XENX STONE MANAGEMENT DEVICE?

The FDA 510(k) record lists Xenolith Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XENX STONE MANAGEMENT DEVICE?

The FDA product code for XENX STONE MANAGEMENT DEVICE is OCY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Xenolith Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113692XENX

Related Devices (Code: OCY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K153264EasyPass GuidewireMedi-Globe CorporationK131072ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICColoplast A/SK124052OSTAVI HYDROPHILIC GUIDEWIRELake Region MedicalK123439NEO ERCP GUIDEWIRENeometrics, Inc.K122816AXCESS SOFT TIP WIRE GUIDEWilson-Cook Medical, Inc.K113692XENXXenolith Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑