Cleared Traditional

K983630 - SEARE BIOMEDICAL SILICONE RODS

K983630 is an FDA 510(k) clearance for SEARE BIOMEDICAL SILICONE RODS, manufactured by Seare Biomedical Corp.. The device is a Class 2 General & Plastic Surgery device with product code MIB cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K983630 · Seare Biomedical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
57d
Days
Class 2
Risk

K983630 is an FDA 510(k) clearance for the SEARE BIOMEDICAL SILICONE RODS. Classified as Elastomer, Silicone Block (product code MIB), Class II - Special Controls.

Submitted by Seare Biomedical Corp. (Salt Lake City, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 874.3620 - 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 - K983630

510(k) Number K983630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1998
Decision Date December 11, 1998
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MIB Device Classification - Class 2, Special Controls

Product Code MIB Elastomer, Silicone Block
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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 - MIB Elastomer, Silicone Block

All 25
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K982065 · Specialty Surgical Products, Inc. · Aug 1998