Cleared Traditional

K162525 - Oniko nail brace (FDA 510(k) Clearance)

K162525 · Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti · General & Plastic Surgery device
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Apr 2018
Decision
593d
Days
-
Risk

K162525 is an FDA 510(k) clearance for the Oniko nail brace. Classified as Prosthesis, Nail (product code MQZ).

Submitted by Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti (Cankaya, TR). The FDA issued a Cleared decision on April 25, 2018 after a review of 593 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti devices

Submission Details

510(k) Number K162525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2016
Decision Date April 25, 2018
Days to Decision 593 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
479d slower than avg
Panel avg: 114d · This submission: 593d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQZ Prosthesis, Nail
Device Class -