SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER— 510(k) K972109

Substantially Equivalent

General Surgical Innovations

FDA 510(k) clearance K972109 for SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER, Substantially Equivalent on 1997-11-14. Applicant: General Surgical Innovations.

Clearance details

Applicant: General Surgical Innovations
Product code: Code FZW
Advisory panel: General, Plastic Surgery
Date received: 1997-06-05
Decision date: 1997-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, 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.