PMA
P980020: Q 103 NEEDLE MANAGEMENT SYSTEM
FDA PMA · Sharps needle destruction device · Qcare International, LLC
Key facts
| PMA number | P980020 |
|---|---|
| Trade name | Q 103 NEEDLE MANAGEMENT SYSTEM |
| Generic name | Sharps needle destruction device |
| Applicant | Qcare International, LLC |
| Product code | MTV |
| Approval date | Dec 21, 2000 |
| Docket number | 00M-1684 |
| Notice date | Jan 3, 2001 |
At a glance
- None Supplements
- Dec 21, 2000 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: