Cleared Traditional

K982753 - SEARE BIOMEDICAL NASAL IMPLANTS

K982753 is an FDA 510(k) clearance for SEARE BIOMEDICAL NASAL IMPLANTS, manufactured by Seare Biomedical Corp.. The device is a Class 2 General & Plastic Surgery device with product code FZE cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K982753 · Seare Biomedical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
55d
Days
Class 2
Risk

K982753 is an FDA 510(k) clearance for the SEARE BIOMEDICAL NASAL IMPLANTS. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Seare Biomedical Corp. (Salt Lake City, US). The FDA issued a Cleared decision on September 30, 1998 after a review of 55 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 Seare Biomedical Corp. devices

FDA 510(k) Submission Details - K982753

510(k) Number K982753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1998
Decision Date September 30, 1998
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
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 21
Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K982753.
Osseointegrated Fixtures
K161548 · Southern Implants (Pty), Ltd. · Dec 2016
NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
K090630 · Nobel Biocare AB · Jun 2009
NASAL DORSAL SERIES
K983755 · Surgical Technology Laboratories, Inc. · Nov 1998
SILIMED NASAL L SHAPED IMPLANT
K981833 · Silimed, LLC · Jun 1998
DURALASTIC ANATOMICAL NASAL IMPLANTS
K973573 · Hanson Medical, Inc. · Nov 1997
DURALASTIC ANATOMICAL NASAL IMPLANTS
K971481 · Allied Biomedical Corp. · Jul 1997