D.L. SCOPE BLADE & HANDLE— 510(k) K841778

Substantially Equivalent

North American Medical Products, Inc.

FDA 510(k) clearance K841778 for D.L. SCOPE BLADE & HANDLE, Substantially Equivalent on 1984-05-23. Applicant: North American Medical Products, Inc..

Clearance details

Applicant
North American Medical Products, Inc.
Product code
Code CCW
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CCW

product code CCW
Death
31
Injury
136
Malfunction
3,703
Other
1
Total
3,871

Source: openFDA MAUDE database, through . 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.