FDA Product Code
FDA Product Code OEW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4560
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143024 | CAS-One Liver | Cascination AG | 2015-04-28 | Traditional | PDF ↗ |
| K101979 | EXPLORER LIVER (PASSIVE TRACKING) | Pathfinder Therapeutics, Inc. | 2011-02-09 | Special | PDF ↗ |
| K093494 | LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM | Pathfinder Therapeutics, Inc. | 2010-03-30 | Special | PDF ↗ |
| K071063 | LINASYS | Pathfinder Therapeutics, Inc. | 2007-12-20 | Traditional | PDF ↗ |
Product code OEW · Class II · Neurology. Data: openFDA.