ECOGEL 200 ULTRASOUND GEL— 510(k) K955246

Substantially Equivalent

Eco-Med Pharmaceuticals, Inc.

FDA 510(k) clearance K955246 for ECOGEL 200 ULTRASOUND GEL, Substantially Equivalent on 1996-02-21. Applicant: Eco-Med Pharmaceuticals, Inc..

Clearance details

Applicant: Eco-Med Pharmaceuticals, Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1995-11-15
Decision date: 1996-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.