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FDA 510(k)

ELIACHAR MODIFIED ESOPHAGEAL STENT

K-Number: K904821 · 1991-01-14

ApplicantHood Laboratories
Decision Date1991-01-14
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELIACHAR MODIFIED ESOPHAGEAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Hood Laboratories. It received FDA 510(k) clearance on 1991-01-14 under 510(k) number K904821. 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 ELIACHAR MODIFIED ESOPHAGEAL STENT?

ELIACHAR MODIFIED ESOPHAGEAL STENT is a medical device that received FDA 510(k) clearance on 1991-01-14. The listed applicant is Hood Laboratories. The 510(k) number is K904821.

When did ELIACHAR MODIFIED ESOPHAGEAL STENT receive FDA 510(k) clearance?

ELIACHAR MODIFIED ESOPHAGEAL STENT received FDA 510(k) clearance on 1991-01-14, under 510(k) number K904821.

Who is the listed applicant for ELIACHAR MODIFIED ESOPHAGEAL STENT?

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

What is the FDA product code for ELIACHAR MODIFIED ESOPHAGEAL STENT?

The FDA product code for ELIACHAR MODIFIED ESOPHAGEAL STENT is ESW.

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Other records listing Hood Laboratories 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.

K921452ACOUSTIC RHINOMETERK920994HOOD NASAL SEPTAL BUTTONK905703KRUPIN EYE VALVE WITH DISKK897049GIBSON ENDOLYMPHATIC SHUNTK897059HOOD SPEAKING VALVEK893866HOOD PEDIATRIC TRACHEOSTOMY 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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