Cleared Traditional

K983792 - SEARE BIOMEDICAL SILICONE TISSUE EXPANDER

K983792 · Seare Biomedical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K983792

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

LCJ Device Classification - Class 0,

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 30
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K983792.
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K130813 · Mentor Corp. · Apr 2013
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500 · Mentor Corp. · Dec 2001
HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS
K983385 · Hutchison Intl., Inc. · Mar 1999
SILIMED TISSUE EXPANDER
K981852 · Silimed, LLC · Aug 1998
MAGNETIC PORT SILICONE TISSUE EXPANDER
K982067 · Specialty Surgical Products, Inc. · Jul 1998
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER
K974209 · Specialty Surgical Products, Inc. · Feb 1998