FUJITSU MALLEABLE - TIP BRAIN SPATULA
Device Facts
| Record ID | K862331 |
|---|---|
| Device Name | FUJITSU MALLEABLE - TIP BRAIN SPATULA |
| Applicant | Downs Surgical , Ltd. |
| Product Code | HAO · Neurology |
| Decision Date | Jul 1, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4535 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.
