Cleared Traditional

K862497 - MICROTEK SEPTAL BUTTON (FDA 510(k) Clearance)

K862497 · Microtek Medical, Inc. · Ear, Nose, Throat device
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Jul 1986
Decision
13d
Days
-
Risk

K862497 is an FDA 510(k) clearance for the MICROTEK SEPTAL BUTTON. Classified as Button, Nasal Septal (product code LFB).

Submitted by Microtek Medical, Inc. (Columbus, US). The FDA issued a Cleared decision on July 14, 1986 after a review of 13 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 Microtek Medical, Inc. devices

Submission Details

510(k) Number K862497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1986
Decision Date July 14, 1986
Days to Decision 13 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
76d faster than avg
Panel avg: 89d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFB Button, Nasal Septal
Device Class -