Cleared Traditional

K865033 - BREAST PROSTHESIS (NON & INFLATABLE) SK...

K865033 · Cox-Uphuff Intl. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
20d
Days
-
Risk

K865033 is an FDA 510(k) clearance for the BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Cox-Uphuff Intl. (Carpinteria, US). The FDA issued a Cleared decision on January 12, 1987 after a review of 20 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 Cox-Uphuff Intl. devices

FDA 510(k) Submission Details - K865033

510(k) Number K865033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1986
Decision Date January 12, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
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 25
Devices cleared under the same product code (LCJ) and FDA review panel - the closest regulatory comparables to K865033.
SURGITEK(R) EXTERNAL FILL PORT
K894495 · Surgitek · Jan 1990
SURGITEK FLAT T-SPAN
K884746 · Medical Engineering Corp. · Aug 1989
RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
K884250 · Mentor Corp. · Jun 1989
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