POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851— 510(k) K030082

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K030082 for POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851, Substantially Equivalent on 2003-10-30. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2003-01-09
Decision date: 2003-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

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.