AUTO SUTURE PITUITARY SPINAL RONGEUR
Device Facts
| Record ID | K943115 |
|---|---|
| Device Name | AUTO SUTURE PITUITARY SPINAL RONGEUR |
| Applicant | United States Surgical, A Division of Tyco Healthc |
| Product Code | HAO · Neurology |
| Decision Date | Jul 25, 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.