Cleared Traditional

K982067 - MAGNETIC PORT SILICONE TISSUE EXPANDER

K982067 · Specialty Surgical Products, Inc. · General & Plastic Surgery device
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Jul 1998
Decision
31d
Days
-
Risk

K982067 is an FDA 510(k) clearance for the MAGNETIC PORT SILICONE 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 July 13, 1998 after a review of 31 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 - K982067

510(k) Number K982067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1998
Decision Date July 13, 1998
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
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 K982067.
HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS
K983385 · Hutchison Intl., Inc. · Mar 1999
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER
K983792 · Seare Biomedical Corp. · Dec 1998
SILIMED TISSUE EXPANDER
K981852 · Silimed, LLC · Aug 1998
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER
K974209 · Specialty Surgical Products, Inc. · Feb 1998
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · Mentor Corp. · Sep 1996
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT
K905484 · Mentor Corp. · Feb 1991