ANSPACH DISSECTION TOOLS— 510(k) K113476

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K113476 for ANSPACH DISSECTION TOOLS, Substantially Equivalent on 2011-12-16. Applicant: The Anspach Effort, Inc..

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code HBE
Advisory panel: Neurology
Date received: 2011-11-22
Decision date: 2011-12-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Palm Beach Gardens, FL, US

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Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

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.