3DSCOPE
Device Facts
| Record ID | K923160 |
|---|---|
| Device Name | 3DSCOPE |
| Applicant | American Surgical Technologies Corp. |
| Product Code | FWF · General, Plastic Surgery |
| Decision Date | Dec 10, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4160 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A surgical camera and accessories is a device intended to be used to record operative procedures.