ANSPACH EMAX DRILL SYSTEM— 510(k) K011444

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K011444 for ANSPACH EMAX DRILL SYSTEM, Substantially Equivalent on 2001-08-08. Applicant: The Anspach Effort, Inc..

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code HBC
Advisory panel: Neurology
Date received: 2001-05-11
Decision date: 2001-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

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Adverse events under product code HBC

product code HBC

Malfunction: 4,715
Total: 4,715

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.