CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER— 510(k) K874276

Name: FDA 510(k) clearance K874276
Creator: U.S. Food and Drug Administration
Published: 1987-12-02

Substantially Equivalent

Cox-Uphuff Intl.

FDA 510(k) clearance K874276 for CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER, Substantially Equivalent on 1987-12-02. Applicant: Cox-Uphuff Intl.. Device class: 1.

Clearance details

Applicant: Cox-Uphuff Intl.
Product code: Code FZW
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-10-20
Decision date: 1987-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZW

view all

K080158 — LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM2008-05-02
K984448 — BIRCOLL BALLOON DISSECTOR1999-01-28
K972109 — SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER1997-11-14
K936186 — AESCULAP SKIN GRAFT MESHER1994-03-10
K904265 — INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER1991-03-06

More clearances from Cox-Uphuff Intl.

view all

K874342 — LIGATURE CARRIER/PACKER, HYDROXYLAPATITE1987-11-13
K873470 — TEMPLATE1987-09-08
K865056 — CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER1987-05-22
K871200 — CUI NASAL SEPTUM BUTTON1987-04-15
K865033 — BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER1987-01-12

Adverse events under product code FZW

product code FZW

Malfunction: 3,067
Total: 3,067

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.