Cleared Special

MICRODOSE CATH, MODELS 90121-201, -202, -203 (K011383) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011383 · Durect Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
49d
Days
Class 2
Risk

K011383 is an FDA 510(k) clearance for the MICRODOSE CATH, MODELS 90121-201, -202, -203. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Durect Corp. (Cupertino, US). The FDA issued a Cleared decision on June 25, 2001 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Durect Corp. devices

Submission Details

510(k) Number K011383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2001
Decision Date June 25, 2001
Days to Decision 49 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 89d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.