Cleared Traditional

SEARE BIOMEDICAL SILICONE TISSUE EXPANDER (K983792) - FDA 510(k) Clearance

K983792 · Seare Biomedical Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 1998
Decision
45d
Days
-
Risk

K983792 is an FDA 510(k) clearance for the SEARE BIOMEDICAL SILICONE TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Seare Biomedical Corp. (Salt Lake City, US). The FDA issued a Cleared decision on December 11, 1998 after a review of 45 days - a notably fast clearance cycle.

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: 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

Submission Details

510(k) Number K983792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1998
Decision Date December 11, 1998
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -