FDA Product Code
FDA Product Code PMU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4050
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250212 | LapBox Power Tissue Containment System | Ark Surgical | 2025-04-15 | Traditional | PDF ↗ |
| K212659 | More-Cell-System | Agency For Medical Innovations GmbH | 2021-11-10 | Traditional | PDF ↗ |
| K192898 | PneumoLiner | Advanced Surgical Concepts | 2020-02-25 | Traditional | PDF ↗ |
| DEN150028 | PneumoLiner | Advanced Surgical Concepts, Ltd. | 2016-04-07 | Direct | — |
Product code PMU · Class II · Obstetrics/Gynecology. Data: openFDA.