← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

LCJ — Tissue Expander And Accessories

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
SU
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K254126AbbVie · 510k2026-01-16
K242963Mentor Worldwide, LLC · 510k2025-04-24
K243836Mentor Worldwide, LLC · 510k2025-01-12

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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