Cleared Traditional

K983385 - HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS

K983385 · Hutchison Intl., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
171d
Days
-
Risk

K983385 is an FDA 510(k) clearance for the HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Hutchison Intl., Inc. (Bethesda, US). The FDA issued a Cleared decision on March 15, 1999 after a review of 171 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hutchison Intl., Inc. devices

FDA 510(k) Submission Details - K983385

510(k) Number K983385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1998
Decision Date March 15, 1999
Days to Decision 171 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
56d slower than avg
Panel avg: 115d · This submission: 171d
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 K983385.
Natrelle 133 Plus Tissue Expander
K143354 · Allergan, Inc. · Aug 2015
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
K130813 · Mentor Corp. · Apr 2013
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500 · Mentor Corp. · Dec 2001
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