Cleared Traditional

K981833 - SILIMED NASAL L SHAPED IMPLANT

K981833 is an FDA 510(k) clearance for SILIMED NASAL L SHAPED IMPLANT, manufactured by Silimed, LLC. The device is a Class 2 General & Plastic Surgery device with product code FZE cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K981833 · Silimed, LLC · General & Plastic Surgery device
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Jun 1998
Decision
31d
Days
Class 2
Risk

K981833 is an FDA 510(k) clearance for the SILIMED NASAL L SHAPED IMPLANT. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Silimed, LLC (Crofton, US). The FDA issued a Cleared decision on June 26, 1998 after a review of 31 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 Silimed, LLC devices

FDA 510(k) Submission Details - K981833

510(k) Number K981833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1998
Decision Date June 26, 1998
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 115d · This submission: 31d
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 13
Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K981833.
Medicon Epiplating System
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NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
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IMPLANTECH JEJ PERI-PYRIFORM IMPLANT
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BA-CPAS
K945154 · Nobelpharma USA, Inc. · Jan 1995
IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
K941960 · Implantech Associates, Inc. · Aug 1994
IMPLANTECH DORSAL NASAL IMPLANT
K942876 · Implantech Associates, Inc. · Jul 1994