Cleared Traditional

OMEGA NASAL SEPTAL BUTTON (K871072) - FDA 510(k) Clearance

K871072 · Omega Silicone, Inc. · Ear, Nose, Throat device
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Jun 1987
Decision
82d
Days
-
Risk

K871072 is an FDA 510(k) clearance for the OMEGA NASAL SEPTAL BUTTON. Classified as Button, Nasal Septal (product code LFB).

Submitted by Omega Silicone, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on June 8, 1987 after a review of 82 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 Omega Silicone, Inc. devices

Submission Details

510(k) Number K871072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1987
Decision Date June 08, 1987
Days to Decision 82 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
7d faster than avg
Panel avg: 89d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFB Button, Nasal Septal
Device Class -