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

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..

Clearance details

Applicant: Cox-Uphuff Intl.
Product code: Code FZW
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 ↗

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.