Cleared Traditional

K904821 - ELIACHAR MODIFIED ESOPHAGEAL STENT

K904821 is the FDA 510(k) clearance for ELIACHAR MODIFIED ESOPHAGEAL STENT by Hood Laboratories. It is a Class 2 Gastroenterology & Urology device (product code ESW) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

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

K904821 is an FDA 510(k) clearance for the ELIACHAR MODIFIED ESOPHAGEAL STENT. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on January 14, 1991 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hood Laboratories devices

Submission Details

510(k) Number K904821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 130d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ESW Prosthesis, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3610
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.