Cleared Traditional

K013987 - REPROCESSED DISPOSABLE TROCARS (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K013987 · Adven Medical · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
87d
Days
Class 1
Risk

K013987 is an FDA 510(k) clearance for the REPROCESSED DISPOSABLE TROCARS. Classified as Trocar, Sinus (product code KBG), Class I - General Controls.

Submitted by Adven Medical (Lubbock, US). The FDA issued a Cleared decision on March 1, 2002 after a review of 87 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 Adven Medical devices

Submission Details

510(k) Number K013987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2001
Decision Date March 01, 2002
Days to Decision 87 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
2d faster than avg
Panel avg: 89d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KBG Trocar, Sinus
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.