PMA
P020008: KARL STORZ AUTOFLUORESCENCE SYSTEM
FDA PMA · SYSTEM, IMAGING, FLUORESCENCE · KARL STORZ Endoscopy-America, Inc.
Key facts
| PMA number | P020008 |
|---|---|
| Trade name | KARL STORZ AUTOFLUORESCENCE SYSTEM |
| Generic name | SYSTEM, IMAGING, FLUORESCENCE |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Owner/operator | KARL STORZ SE & CO KG |
| Product code | MRK |
| Approval date | Dec 12, 2002 |
| Docket number | 03M-0011 |
| Notice date | Jan 22, 2003 |
| Establishment registration | 3010202439 |
| FEI number | 3007475226 |
At a glance
- 1–9 Supplements
- Dec 23, 2009 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: