CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER— 510(k) K865056

Clearance details

Applicant

Cox-Uphuff Intl.

Product code

Code LCJ

Device class

Unclassified

Advisory panel

Unknown

Date received

1986-12-24

Decision date

1987-05-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Santa Barbara, CA, US

• K254126 — Natrelle 133S Tissue Expanders2026-01-16
• K242963 — MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs2025-04-24
• K243836 — Mentor CPX 4 PLUS Enhance Breast Tissue Expander2025-01-12
• K241918 — MENTOR CPX4 PLUS Enhance Breast Tissue Expander2024-08-02
• K211676 — Motiva Flora SmoothSilk Tissue Expander2023-10-13

• K874276 — CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER1987-12-02
• K874342 — LIGATURE CARRIER/PACKER, HYDROXYLAPATITE1987-11-13
• K873470 — TEMPLATE1987-09-08
• K871200 — CUI NASAL SEPTUM BUTTON1987-04-15
• K865033 — BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER1987-01-12

Injury

2,704

Other

2

Total

2,706

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2104-2015 — Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.Class II·Terminated·Allergan Inc·20150618

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K865056.