Cleared Traditional

K884250 - RADOVAN TISSUE EXPANDER (OPTION INTEGRA...

K884250 · Mentor Corp. · General & Plastic Surgery device
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Jun 1989
Decision
244d
Days
-
Risk

K884250 is an FDA 510(k) clearance for the RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.). Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on June 12, 1989 after a review of 244 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.

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Submission Details

510(k) Number K884250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1988
Decision Date June 12, 1989
Days to Decision 244 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 115d · This submission: 244d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -

Regulatory Peers - LCJ Tissue Expander And Accessories

All 20
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K884250.
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · Mentor Corp. · Sep 1996
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT
K905484 · Mentor Corp. · Feb 1991
MENTOR TISSUE EXPANDERS W/TDMAC COATING
K894475 · Mentor Corp. · Nov 1990
MENTOR FLAT-SPAN
K862049 · Mentor Corp. · Jun 1986
MENTOR EXPANDER MAMMARY PROSTHESIS
K844813 · Mentor Corp. · May 1985
RADOVAN TISSUE EXPANDER
K842883 · Mentor Corp. · Aug 1984