Cleared Traditional

MICROMEDICS NASAL SEPTAL BUTTON (K982667) - FDA 510(k) Clearance

K982667 · Micromedics, Inc. · Ear, Nose, Throat device
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Nov 1998
Decision
116d
Days
-
Risk

K982667 is an FDA 510(k) clearance for the MICROMEDICS NASAL SEPTAL BUTTON. Classified as Button, Nasal Septal (product code LFB).

Submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on November 24, 1998 after a review of 116 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Micromedics, Inc. devices

Submission Details

510(k) Number K982667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1998
Decision Date November 24, 1998
Days to Decision 116 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 89d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFB Button, Nasal Septal
Device Class -