Cleared Traditional

K823916 - WAX CURETTE TIP (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K823916 · Treace Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1983
Decision
24d
Days
Class 1
Risk

K823916 is an FDA 510(k) clearance for the WAX CURETTE TIP. Classified as Curette, Ear (product code JYG), Class I - General Controls.

Submitted by Treace Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983 after a review of 24 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 Treace Medical, Inc. devices

Submission Details

510(k) Number K823916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1982
Decision Date January 21, 1983
Days to Decision 24 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
65d faster than avg
Panel avg: 89d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.