Cleared Traditional

K871071 - OMEGA DORSAL COLUMELLA IMPLANTS

K871071 is an FDA 510(k) clearance for OMEGA DORSAL COLUMELLA IMPLANTS, manufactured by Omega Silicone, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZE cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K871071 · Omega Silicone, Inc. · General & Plastic Surgery device
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Apr 1987
Decision
26d
Days
Class 2
Risk

K871071 is an FDA 510(k) clearance for the OMEGA DORSAL COLUMELLA IMPLANTS. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Omega Silicone, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on April 13, 1987 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3680 - the FDA general and plastic surgery device framework. 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

FDA 510(k) Submission Details - K871071

510(k) Number K871071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1987
Decision Date April 13, 1987
Days to Decision 26 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZE Device Classification - Class 2, Special Controls

Product Code FZE Prosthesis, Nose, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZE Prosthesis, Nose, Internal

All 16
Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K871071.
FLOWERS NASAL IMPLANT
K904656 · Implantech Associates, Inc. · Dec 1990
FLOWERS DORSAL COLUMELLA IMPLANT
K904657 · Implantech Associates, Inc. · Dec 1990
SILASTIC NASAL IMPLANT S-TYPE
K880405 · Dow Corning Wright · Feb 1988
BYRON NASAL SEPTAL BUTTON
K863398 · Byron Medical · Sep 1986
BYRON DORSAL COLUMELLA IMPLANT
K863399 · Byron Medical · Sep 1986
BYRON BIVALVE NASAL SPLINTS
K863430 · Byron Medical · Sep 1986