DACOMED EXTERNAL MALE CONTINENCE DEVICE
Device Facts
| Record ID | K885323 |
|---|---|
| Device Name | DACOMED EXTERNAL MALE CONTINENCE DEVICE |
| Applicant | Dacomed Corp. |
| Product Code | FHA · Gastroenterology, Urology |
| Decision Date | Feb 8, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5160 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.
