4-LEAD IRRIGATION SET— 510(k) K942101

Substantially Equivalent

Douglas Medical Products Corp.

FDA 510(k) clearance K942101 for 4-LEAD IRRIGATION SET, Substantially Equivalent on 1994-09-30. Applicant: Douglas Medical Products Corp..

Clearance details

Applicant: Douglas Medical Products Corp.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1994-05-02
Decision date: 1994-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, 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.