AquaFlate Pre-Filled Sterile Water Syringe 10mL— 510(k) K200556

Substantially Equivalent

H R Pharmaceuticals, Inc.

FDA 510(k) clearance K200556 for AquaFlate Pre-Filled Sterile Water Syringe 10mL, Substantially Equivalent on 2020-03-31. Applicant: H R Pharmaceuticals, Inc..

Clearance details

Applicant: H R Pharmaceuticals, Inc.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2020-03-03
Decision date: 2020-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.