Hi bebe super (BT-150B)— 510(k) K251512

Substantially Equivalent

Bistos Co., Ltd.

FDA 510(k) clearance K251512 for Hi bebe super (BT-150B), Substantially Equivalent on 2025-09-25. Applicant: Bistos Co., Ltd..

Clearance details

Applicant: Bistos Co., Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2025-05-16
Decision date: 2025-09-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

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.