GALLINI ATRA-CUT NEEDLE— 510(k) K990645

Substantially Equivalent

Gallini U.S., LLC

FDA 510(k) clearance K990645 for GALLINI ATRA-CUT NEEDLE, Substantially Equivalent on 1999-05-19. Applicant: Gallini U.S., LLC.

Clearance details

Applicant: Gallini U.S., LLC
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 1999-02-26
Decision date: 1999-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.