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)

BONASTENT BILIARY

K-Number: K093003 · 2010-03-24

Decision Date2010-03-24
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

BONASTENT BILIARY is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2010-03-24 under 510(k) number K093003. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the BONASTENT BILIARY?

BONASTENT BILIARY is a medical device that received FDA 510(k) clearance on 2010-03-24. The listed applicant is Endochoice, Inc.. The 510(k) number is K093003.

When did BONASTENT BILIARY receive FDA 510(k) clearance?

BONASTENT BILIARY received FDA 510(k) clearance on 2010-03-24, under 510(k) number K093003.

Who is the listed applicant for BONASTENT BILIARY?

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

What is the FDA product code for BONASTENT BILIARY?

The FDA product code for BONASTENT BILIARY is FGE.

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.

Other records listing Endochoice, 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.

View all 17 devices →

Related Devices (Code: FGE)

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.

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.

↑