DX101-T ULTRASONIC SURGICAL SYSTEM— 510(k) K880815

Substantially Equivalent

Niic U.S.A., Inc.

FDA 510(k) clearance K880815 for DX101-T ULTRASONIC SURGICAL SYSTEM, Substantially Equivalent on 1988-04-13. Applicant: Niic U.S.A., Inc..

Clearance details

Applicant: Niic U.S.A., Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 1988-02-17
Decision date: 1988-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

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Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.