ANSPACH LUBRICATING SYSTEM II— 510(k) K970530

Substantially Equivalent

The Anspach Effort, Inc.

FDA 510(k) clearance K970530 for ANSPACH LUBRICATING SYSTEM II, Substantially Equivalent on 1997-05-05. Applicant: The Anspach Effort, Inc..

Clearance details

Applicant: The Anspach Effort, Inc.
Product code: Code GEY
Advisory panel: General, Plastic Surgery
Date received: 1997-02-12
Decision date: 1997-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

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Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

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.