EG-3800T, VIDEO GASTROSCOPE— 510(k) K962460

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K962460 for EG-3800T, VIDEO GASTROSCOPE, Substantially Equivalent on 1996-09-16. Applicant: Pentax Precision Instrument Corp..

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code FDS
Advisory panel: Gastroenterology, Urology
Date received: 1996-06-25
Decision date: 1996-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miramar, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

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.