Cleared Traditional

K011544 - HADGEL

K011544 is an FDA 510(k) clearance for HADGEL, manufactured by Seikagaku Corp.. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K011544 · Seikagaku Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K011544

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.

LYA Device Classification - Class 1, General Controls

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.

Regulatory Peers - LYA Splint, Intranasal Septal

All 19
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K011544.
ARTHROCARE NASASTENT CMC NASAL DRESSING
K140992 · ArthroCare Corporation · Jun 2014
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · Medtronic Xomed, Inc. · Sep 2004
SEPRAGEL SINUS
K012532 · Genzyme Corp. · Oct 2001
LACTOSORB ETHMOID STENT
K002131 · Walter Lorenz Surgical, Inc. · Apr 2001
BIVALVE NASAL SPLINT
K972096 · Boston Medical Products, Inc. · Jul 1997
NASAL AIRWAY SPLINT
K972092 · Boston Medical Products, Inc. · Jul 1997