SHARPS CONTAINMENT SYSTEM— 510(k) K925816

Substantially Equivalent

Post Medical, Inc.

FDA 510(k) clearance K925816 for SHARPS CONTAINMENT SYSTEM, Substantially Equivalent on 1994-04-29. Applicant: Post Medical, Inc..

Clearance details

Applicant
Post Medical, Inc.
Product code
Code FMI
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Atlanta, GA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FMI

product code FMI
Death
28
Injury
1,517
Malfunction
23,981
Other
18
Total
25,544

Source: openFDA MAUDE database, through . 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.