SURGICAL TISSUE POUCH
Device Facts
| Record ID | K910914 |
|---|---|
| Device Name | SURGICAL TISSUE POUCH |
| Applicant | Cook Urological, Inc. |
| Product Code | KGY · General, Plastic Surgery |
| Decision Date | Mar 28, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4100 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.