510(k) K233020— TauTona Pneumoperitoneum Assist Device (TPAD)

Substantially Equivalent

Tautona Group Research & Development, Co., LLC

Clearance details

Applicant: Tautona Group Research & Development, Co., LLC
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2023-09-22
Decision date: 2024-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

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.