NeuroLine Disposable Cranial Perforator with Hudson end— 510(k) K213228

Substantially Equivalent

Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.

FDA 510(k) clearance K213228 for NeuroLine Disposable Cranial Perforator with Hudson end, Substantially Equivalent on 2022-06-20. Applicant: Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft..

Clearance details

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

Download summary PDF View on FDA.gov ↗

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.