AUTO SUTURE SPINAL OSTEOTOME
Device Facts
| Record ID | K942968 |
|---|---|
| Device Name | AUTO SUTURE SPINAL OSTEOTOME |
| Applicant | United States Surgical, A Division of Tyco Healthc |
| Product Code | HAO · Neurology |
| Decision Date | Jul 20, 1994 |
| 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.
