510(k) K945590— SCOPETEX(TM)

Substantially Equivalent

Smith Helms Mulliss & Moore, L.L.P.

Clearance details

Applicant: Smith Helms Mulliss & Moore, L.L.P.
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 1994-11-14
Decision date: 1997-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greensboro, NC, US

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, 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.