IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS
Device Facts
| Record ID | K911163 |
|---|---|
| Device Name | IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS |
| Applicant | Imagyn Medical, Inc. |
| Product Code | FWF · General, Plastic Surgery |
| Decision Date | Jun 3, 1991 |
| 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.