DOFI RASTER-SCREEN— 510(k) K943554

Substantially Equivalent

Howrey & Simon

FDA 510(k) clearance K943554 for DOFI RASTER-SCREEN, Substantially Equivalent on 1995-03-01. Applicant: Howrey & Simon.

Clearance details

Applicant: Howrey & Simon
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1994-07-21
Decision date: 1995-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.