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)

NEO ERCP GUIDEWIRE

K-Number: K123439 · 2013-01-03

ApplicantNeometrics, Inc.
Decision Date2013-01-03
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEO ERCP GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Neometrics, Inc.. It received FDA 510(k) clearance on 2013-01-03 under 510(k) number K123439. 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 NEO ERCP GUIDEWIRE?

NEO ERCP GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2013-01-03. The listed applicant is Neometrics, Inc.. The 510(k) number is K123439.

When did NEO ERCP GUIDEWIRE receive FDA 510(k) clearance?

NEO ERCP GUIDEWIRE received FDA 510(k) clearance on 2013-01-03, under 510(k) number K123439.

Who is the listed applicant for NEO ERCP GUIDEWIRE?

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

What is the FDA product code for NEO ERCP GUIDEWIRE?

The FDA product code for NEO ERCP GUIDEWIRE 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 Neometrics, Inc. 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.

K101729NEOWIRE PTA/PTCA GUIDEWIREK070150VASCUPUNCTURE PICC GUIDEWIREK043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREK040786VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATINGK033321SELECTIVA SB GUIDEWIREK031652VASCUPUNCTURE PICC GUIDEWIRE

View all 17 devices →

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 MedicalK123438XENX STONE MANAGEMENT DEVICEXenolith MedicalK122816AXCESS 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.

↑