SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER— 510(k) K902349

Substantially Equivalent

Surgitek

FDA 510(k) clearance K902349 for SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER, Substantially Equivalent on 1990-09-05. Applicant: Surgitek.

Clearance details

Applicant: Surgitek
Product code: Code FZW
Advisory panel: General, Plastic Surgery
Date received: 1990-05-25
Decision date: 1990-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paso Robles, 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.