INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER— 510(k) K904265

Substantially Equivalent

Inamed Development Co.

FDA 510(k) clearance K904265 for INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER, Substantially Equivalent on 1991-03-06. Applicant: Inamed Development Co..

Clearance details

Applicant: Inamed Development Co.
Product code: Code FZW
Advisory panel: General, Plastic Surgery
Date received: 1990-09-18
Decision date: 1991-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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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.