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)

BILE ENDOPROSTHESIS SET

K-Number: K860534 · 1986-03-10

ApplicantAngiomed U.S., Inc.
Decision Date1986-03-10
Product CodeGBZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BILE ENDOPROSTHESIS SET is the device name listed in this FDA 510(k) record. The listed applicant is Angiomed U.S., Inc.. It received FDA 510(k) clearance on 1986-03-10 under 510(k) number K860534. The device is classified under product code GBZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILE ENDOPROSTHESIS SET?

BILE ENDOPROSTHESIS SET is a medical device that received FDA 510(k) clearance on 1986-03-10. The listed applicant is Angiomed U.S., Inc.. The 510(k) number is K860534.

When did BILE ENDOPROSTHESIS SET receive FDA 510(k) clearance?

BILE ENDOPROSTHESIS SET received FDA 510(k) clearance on 1986-03-10, under 510(k) number K860534.

Who is the listed applicant for BILE ENDOPROSTHESIS SET?

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

What is the FDA product code for BILE ENDOPROSTHESIS SET?

The FDA product code for BILE ENDOPROSTHESIS SET is GBZ.

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 Angiomed U.S., 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.

K874771ANGIOMED INTRODUCING SETSK874585ANGIOMED OSTY-CUT BONE BIOPSY NEEDLEK864225ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENTK863386VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETSK862805ANGIOMED VAC-U-CUT BIOPSY NEEDLEK863446ANGIOMED HIGH PRESSURE CONNECTORS

View all 24 devices →

Related Devices (Code: GBZ)

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.

K973621PRE-VIEW CHOLANGIOGRAPHY CLAMPNashville Surgical InstrumentsK944790FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERApplied Medical ResourcesK942450ENDOPATHEthicon Endo-Surgery, Inc.K932228MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETERBoston Scientific CorpK926217TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USETerumo Medical Corp.K926143ANGIOLAPCATH CHOLANGIOGRAPHY KITBd Becton Dickinson Vacutainer Systems Preanalytic

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.

↑