Cleared Traditional

K974209 - SILICONE TISSUE/INFLATABLE TISSUE EXPANDER

K974209 · Specialty Surgical Products, Inc. · General & Plastic Surgery device
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Feb 1998
Decision
88d
Days
-
Risk

K974209 is an FDA 510(k) clearance for the SILICONE TISSUE/INFLATABLE TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Specialty Surgical Products, Inc. (Hamilton, US). The FDA issued a Cleared decision on February 6, 1998 after a review of 88 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 Specialty Surgical Products, Inc. devices

FDA 510(k) Submission Details - K974209

510(k) Number K974209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1997
Decision Date February 06, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
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 39
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K974209.
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER
K983792 · Seare Biomedical Corp. · Dec 1998
SILIMED TISSUE EXPANDER
K981852 · Silimed, LLC · Aug 1998
MAGNETIC PORT SILICONE TISSUE EXPANDER
K982067 · Specialty Surgical Products, Inc. · Jul 1998
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · Mentor Corp. · Sep 1996
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT
K905484 · Mentor Corp. · Feb 1991
SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER
K903448 · Medical Engineering Corp. · Jan 1991