LAPARASCOPE— 510(k) K943662

Substantially Equivalent

Pollux Endoscopy, Inc.

FDA 510(k) clearance K943662 for LAPARASCOPE, Substantially Equivalent on 1995-05-25. Applicant: Pollux Endoscopy, Inc..

Clearance details

Applicant: Pollux Endoscopy, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1994-07-28
Decision date: 1995-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunrise, FL, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.