Cleared Traditional

K862049 - MENTOR FLAT-SPAN

K862049 · Mentor Corp. · General & Plastic Surgery device
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Jun 1986
Decision
12d
Days
-
Risk

K862049 is an FDA 510(k) clearance for the MENTOR FLAT-SPAN. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on June 10, 1986 after a review of 12 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 Mentor Corp. devices

Submission Details

510(k) Number K862049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1986
Decision Date June 10, 1986
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
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 K862049.
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT
K905484 · Mentor Corp. · Feb 1991
MENTOR TISSUE EXPANDERS W/TDMAC COATING
K894475 · Mentor Corp. · Nov 1990
RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
K884250 · Mentor Corp. · Jun 1989
MENTOR EXPANDER MAMMARY PROSTHESIS
K844813 · Mentor Corp. · May 1985
RADOVAN TISSUE EXPANDER
K842883 · Mentor Corp. · Aug 1984
SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE
K801042 · Dow Corning Corp. Healthcare Industries Materials · Jun 1980