LAPAROSHIELD CONDITIONED INSUFFLATION SET— 510(k) K030469

Substantially Equivalent

Pall Medical

FDA 510(k) clearance K030469 for LAPAROSHIELD CONDITIONED INSUFFLATION SET, Substantially Equivalent on 2003-05-09. Applicant: Pall Medical.

Clearance details

Applicant: Pall Medical
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2003-02-12
Decision date: 2003-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.