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

Name: FDA 510(k) clearance K213228
Creator: U.S. Food and Drug Administration
Published: 2022-06-20

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.. Device class: 2.

Clearance details

Applicant: Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
Product code: Code HBF
Device class: Class 2
Regulation: 21 CFR 882.4305
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 ↗

Recent devices under product code HBF

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K254177 — Disposable Sterile Skull Drill (LZ)2026-09-11
K231403 — evoDrill Cranial Perforator2024-03-06
K183581 — Codman Disposable Perforators2019-01-20
K141455 — EASYDRILL AUTOSTOP CRANIAL PERFORATOR2015-03-16
K121253 — MERIDIAN CRANIAL PERFORATOR2012-07-17

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.