Cleared Traditional

K852039 - FLEX-LOOP FLEXIBLE EAR CORETTE

K852039 is an FDA 510(k) clearance for FLEX-LOOP FLEXIBLE EAR CORETTE, manufactured by Bionix Corp.. The device is a Class 1 Ear, Nose, Throat device with product code JYG cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K852039 · Bionix Corp. · Ear, Nose, Throat device
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Jun 1985
Decision
33d
Days
Class 1
Risk

K852039 is an FDA 510(k) clearance for the FLEX-LOOP FLEXIBLE EAR CORETTE. Classified as Curette, Ear (product code JYG), Class I - General Controls.

Submitted by Bionix Corp. (Holland, US). The FDA issued a Cleared decision on June 11, 1985 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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 Bionix Corp. devices

FDA 510(k) Submission Details - K852039

510(k) Number K852039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1985
Decision Date June 11, 1985
Days to Decision 33 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 89d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

JYG Device Classification - Class 1, General Controls

Product Code JYG Curette, Ear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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.