Cleared Traditional

HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS (K983385) - FDA 510(k) Clearance

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

Submission Details

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
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 115d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -