SiO2 Coated syringe 3 ml— 510(k) K153553

Substantially Equivalent

Sio2 Medical Products

FDA 510(k) clearance K153553 for SiO2 Coated syringe 3 ml, Substantially Equivalent on 2016-05-17. Applicant: Sio2 Medical Products.

Clearance details

Applicant: Sio2 Medical Products
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2015-12-11
Decision date: 2016-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auburn, AL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.