CRANIAL PERFORATOR— 510(k) K082637

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K082637 for CRANIAL PERFORATOR, Substantially Equivalent on 2008-12-22. Applicant: The Anspach Effort, Inc..

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code HBF
Advisory panel: Neurology
Date received: 2008-09-10
Decision date: 2008-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

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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.