Cleared Traditional

HADGEL, 4 GRAM/SYRINGE (K011544) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K011544 · Seikagaku Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Aug 2001
Decision
89d
Days
Class 1
Risk

K011544 is an FDA 510(k) clearance for the HADGEL, 4 GRAM/SYRINGE. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Seikagaku Corp. (Kitty Hawk, US). The FDA issued a Cleared decision on August 15, 2001 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4780 - the FDA ear, nose and throat 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 Seikagaku Corp. devices

Submission Details

510(k) Number K011544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2001
Decision Date August 15, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 89d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.