510(k) K905459— SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM

Substantially Equivalent

Angiosystems, Inc.

Clearance details

Applicant: Angiosystems, Inc.
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 1990-12-05
Decision date: 1991-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.