ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II— 510(k) K030576

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K030576 for ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II, Substantially Equivalent on 2003-05-21. Applicant: The Anspach Effort, Inc..

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2003-02-24
Decision date: 2003-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.