BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM— 510(k) K091958

Substantially Equivalent

Glenveigh Surgical, LLC

FDA 510(k) clearance K091958 for BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM, Substantially Equivalent on 2010-04-30. Applicant: Glenveigh Surgical, LLC.

Clearance details

Applicant: Glenveigh Surgical, LLC
Product code: Code OQY
Advisory panel: Obstetrics/Gynecology
Date received: 2009-07-01
Decision date: 2010-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Swanee, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OQY

product code OQY

Death: 8
Injury: 616
Malfunction: 500
Total: 1,124

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.