EUP-OL334 LAPARASCOPICPROBE— 510(k) K981434

Substantially Equivalent

Hitachi Medical Corp. of America

FDA 510(k) clearance K981434 for EUP-OL334 LAPARASCOPICPROBE, Substantially Equivalent on 1998-07-27. Applicant: Hitachi Medical Corp. of America.

Clearance details

Applicant: Hitachi Medical Corp. of America
Product code: Code ITX
Advisory panel: Radiology
Date received: 1998-04-21
Decision date: 1998-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saratoga, CA, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.