SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS— 510(k) K883091

Substantially Equivalent

Sharplan Lasers, Inc.

FDA 510(k) clearance K883091 for SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS, Substantially Equivalent on 1988-10-14. Applicant: Sharplan Lasers, Inc..

Clearance details

Applicant: Sharplan Lasers, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 1988-07-22
Decision date: 1988-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, 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.