K213228

Substantially Equivalent

NeuroLine Disposable Cranial Perforator with Hudson end

Applicant: Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
Product code: HBF
Advisory panel: Neurology
Date received: 2021-09-29
Decision date: 2022-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Debrecen, HU

Adverse events under product code HBF

product code HBF

Injury: 587
Malfunction: 621
Other: 1
Total: 1,209

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.