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)

FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS

K-Number: K984068 · 1999-01-07

ApplicantSchneider (Europe) GmbH
Decision Date1999-01-07
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Schneider (Europe) GmbH. It received FDA 510(k) clearance on 1999-01-07 under 510(k) number K984068. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS?

FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS is a medical device that received FDA 510(k) clearance on 1999-01-07. The listed applicant is Schneider (Europe) GmbH. The 510(k) number is K984068.

When did FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS receive FDA 510(k) clearance?

FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS received FDA 510(k) clearance on 1999-01-07, under 510(k) number K984068.

Who is the listed applicant for FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS?

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

What is the FDA product code for FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS?

The FDA product code for FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS is ESW.

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 Schneider (Europe) GmbH 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.

K982592DOCKING-EXTENSION WIREK970528CLYDE CORONARY GUIDEWIREK970494HANNIBAL GUIDEWIREK951109C-THRU CORONARY GUIDE WIRE

Related Devices (Code: ESW)

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.

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific CorporationK243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston ScientificK233837Agile Esophageal Stent SystemBoston Scientific Corporation

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.

↑