SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE— 510(k) K063688

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K063688 for SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE, Substantially Equivalent on 2007-01-16. Applicant: The Anspach Effort, Inc..

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code HWE
Advisory panel: General, Plastic Surgery
Date received: 2006-12-12
Decision date: 2007-01-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Palm Beach Gardens, FL, US

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Adverse events under product code HWE

product code HWE

Death: 4
Injury: 448
Malfunction: 19,856
Other: 2
Total: 20,310

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.