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FDA 510(k)

WALLSTENT ESOPHAGEAL PROTHESIS

K-Number: K923119 · 1992-09-01

ApplicantSchneider U.S. Stent Div.
Decision Date1992-09-01
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WALLSTENT ESOPHAGEAL PROTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Schneider U.S. Stent Div.. It received FDA 510(k) clearance on 1992-09-01 under 510(k) number K923119. 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 WALLSTENT ESOPHAGEAL PROTHESIS?

WALLSTENT ESOPHAGEAL PROTHESIS is a medical device that received FDA 510(k) clearance on 1992-09-01. The listed applicant is Schneider U.S. Stent Div.. The 510(k) number is K923119.

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

WALLSTENT ESOPHAGEAL PROTHESIS received FDA 510(k) clearance on 1992-09-01, under 510(k) number K923119.

Who is the listed applicant for WALLSTENT ESOPHAGEAL PROTHESIS?

The FDA 510(k) record lists Schneider U.S. Stent Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WALLSTENT ESOPHAGEAL PROTHESIS?

The FDA product code for WALLSTENT ESOPHAGEAL PROTHESIS 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 U.S. Stent Div. 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.

K923993WALLSTENT BILIARY ENDOPROTHESESK914277WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY

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.

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