ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM— 510(k) K061297

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K061297 for ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM, Substantially Equivalent on 2007-01-26. Applicant: The Anspach Effort, Inc..

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code HBB
Advisory panel: Neurology
Date received: 2006-05-09
Decision date: 2007-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

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Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

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.