ANSPACH SHIELDED ATTACHMENT— 510(k) K974025

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K974025 for ANSPACH SHIELDED ATTACHMENT, Substantially Equivalent on 1998-07-06. Applicant: The Anspach Effort, Inc..

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code GFF
Advisory panel: General, Plastic Surgery
Date received: 1997-10-23
Decision date: 1998-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

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Adverse events under product code GFF

product code GFF

Malfunction: 459
Other: 1
Total: 460

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.