Cleared Traditional

ELIACHAR MODIFIED ESOPHAGEAL STENT

K904821 · Hood Laboratories · Gastroenterology & Urology
Jan 1991
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K904821 is an FDA 510(k) clearance for the ELIACHAR MODIFIED ESOPHAGEAL STENT, a Prosthesis, Esophageal (Class II — Special Controls, product code ESW), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on January 14, 1991, 82 days after receiving the submission on October 24, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number K904821 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 1990
Decision Date January 14, 1991
Days to Decision 82 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code ESW — Prosthesis, Esophageal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3610

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