Cleared Traditional

SILMED NASAL SEPTAL BUTTON (K013696) - FDA 510(k) Clearance

K013696 · Silmed, Inc. · Ear, Nose, Throat device
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Nov 2001
Decision
21d
Days
-
Risk

K013696 is an FDA 510(k) clearance for the SILMED NASAL SEPTAL BUTTON. Classified as Button, Nasal Septal (product code LFB).

Submitted by Silmed, Inc. (Leesburg,, US). The FDA issued a Cleared decision on November 28, 2001 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel. 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 Silmed, Inc. devices

Submission Details

510(k) Number K013696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date November 28, 2001
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFB Button, Nasal Septal
Device Class -