INSTRUMENTS NONSTERILE & STERILE
Device Facts
| Record ID | K802726 |
|---|---|
| Device Name | INSTRUMENTS NONSTERILE & STERILE |
| Applicant | Ascep, Inc. |
| Product Code | HAO · Neurology |
| Decision Date | Nov 19, 1980 |
| 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.
