Cleared Traditional

K901366 - INVOTEC SEPTAL BUTTON (FDA 510(k) Clearance)

K901366 · Invotec International, Inc. · Ear, Nose, Throat device
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Jun 1990
Decision
83d
Days
-
Risk

K901366 is an FDA 510(k) clearance for the INVOTEC SEPTAL BUTTON. Classified as Button, Nasal Septal (product code LFB).

Submitted by Invotec International, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 14, 1990 after a review of 83 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 Invotec International, Inc. devices

Submission Details

510(k) Number K901366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1990
Decision Date June 14, 1990
Days to Decision 83 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
6d faster than avg
Panel avg: 89d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFB Button, Nasal Septal
Device Class -