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FDA 510(k)

RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM

K-Number: K010068 · 2001-02-08

ApplicantRusch Intl.
Decision Date2001-02-08
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 2001-02-08 under 510(k) number K010068. 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 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM?

RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM is a medical device that received FDA 510(k) clearance on 2001-02-08. The listed applicant is Rusch Intl.. The 510(k) number is K010068.

When did RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM receive FDA 510(k) clearance?

RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM received FDA 510(k) clearance on 2001-02-08, under 510(k) number K010068.

Who is the listed applicant for RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM?

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

What is the FDA product code for RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM?

The FDA product code for RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM is ESW.

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Other records listing Rusch Intl. 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.

K033023INTERMITTENT URETHRAL CATHETERSK030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEMK023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETERK023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESSK023964RUSCH MICROLARYNGEAL TUBEK021540RUSCH EDGAR TUBE

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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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