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FDA 510(k)

INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM

K-Number: K955041 · 1996-02-21

ApplicantInstent, Inc.
Decision Date1996-02-21
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Instent, Inc.. It received FDA 510(k) clearance on 1996-02-21 under 510(k) number K955041. 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 INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM?

INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-21. The listed applicant is Instent, Inc.. The 510(k) number is K955041.

When did INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM receive FDA 510(k) clearance?

INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM received FDA 510(k) clearance on 1996-02-21, under 510(k) number K955041.

Who is the listed applicant for INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM?

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

What is the FDA product code for INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM?

The FDA product code for INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM is ESW.

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Other records listing Instent, 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.

K945498INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESISK924387INSTENT ENDOCOIL BILIARY ENDOPROSTHESISK941487INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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