MERIDIAN CRANIAL PERFORATOR— 510(k) K121253

Name: FDA 510(k) clearance K121253
Creator: U.S. Food and Drug Administration
Published: 2012-07-17

Substantially Equivalent

Adeor Medical Technologies GmbH

FDA 510(k) clearance K121253 for MERIDIAN CRANIAL PERFORATOR, Substantially Equivalent on 2012-07-17. Applicant: Adeor Medical Technologies GmbH. Device class: 2.

Clearance details

Applicant: Adeor Medical Technologies GmbH
Product code: Code HBF
Device class: Class 2
Regulation: 21 CFR 882.4305
Advisory panel: Neurology
Date received: 2012-04-25
Decision date: 2012-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pullach, DE

Download summary PDF View on FDA.gov ↗

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K141455 — EASYDRILL AUTOSTOP CRANIAL PERFORATOR2015-03-16

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.