Cleared Traditional

K872609 - CURETTE SET, ANTRUM, COAKLEY (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K872609 · Military Engineering, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1987
Decision
9d
Days
Class 1
Risk

K872609 is an FDA 510(k) clearance for the CURETTE SET, ANTRUM, COAKLEY. Classified as Curette, Nasal (product code KAP), Class I - General Controls.

Submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 15, 1987 after a review of 9 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 Military Engineering, Inc. devices

Submission Details

510(k) Number K872609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date July 15, 1987
Days to Decision 9 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
80d faster than avg
Panel avg: 89d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAP Curette, Nasal
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.