ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011— 510(k) K940179

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K940179 for ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011, Substantially Equivalent on 1995-05-23. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1994-01-12
Decision date: 1995-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.