QUICKCLOT— 510(k) K013390

Substantially Equivalent

On Site Gas Systems, Inc.

FDA 510(k) clearance K013390 for QUICKCLOT, Substantially Equivalent on 2002-05-23. Applicant: On Site Gas Systems, Inc..

Clearance details

Applicant: On Site Gas Systems, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2001-10-15
Decision date: 2002-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newington, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.