GESCO PER-Q-CATH REPAIR KIT— 510(k) K910622

Unknown

Gesco Intl., Inc.

FDA 510(k) clearance K910622 for GESCO PER-Q-CATH REPAIR KIT, Unknown on 1991-03-29. Applicant: Gesco Intl., Inc..

Clearance details

Applicant: Gesco Intl., Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 1991-02-12
Decision date: 1991-03-29
Decision: Unknown
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.