Cleared Traditional

K925426 - RIZZO NASAL IMPLANT

K925426 is an FDA 510(k) clearance for RIZZO NASAL IMPLANT, manufactured by Implantech Associates, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZE cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K925426 · Implantech Associates, Inc. · General & Plastic Surgery device
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May 1993
Decision
197d
Days
Class 2
Risk

K925426 is an FDA 510(k) clearance for the RIZZO NASAL IMPLANT. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on May 12, 1993 after a review of 197 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Implantech Associates, Inc. devices

FDA 510(k) Submission Details - K925426

510(k) Number K925426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1992
Decision Date May 12, 1993
Days to Decision 197 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 115d · This submission: 197d
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 23
Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K925426.
IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
K941960 · Implantech Associates, Inc. · Aug 1994
IMPLANTECH DORSAL NASAL IMPLANT
K942876 · Implantech Associates, Inc. · Jul 1994
NASAL DORSUM
K925743 · Smith & Nephew Richards, Inc. · Aug 1993
BRINK PRE-MAXILLARY IMPLANT
K921580 · Implantech Associates, Inc. · May 1992
FLOWERS NASAL IMPLANT
K904656 · Implantech Associates, Inc. · Dec 1990
FLOWERS DORSAL COLUMELLA IMPLANT
K904657 · Implantech Associates, Inc. · Dec 1990