EXI — Device, Paste-On For Incontinence, Sterile Class I
FDA Device Classification
Classification Details
- Product Code
- EXI
- Device Class
- Class I
- Regulation Number
- 876.5250
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K971499 | mediquest | FEMALE EXTERNAL URINARY COLLECTION POUCH | August 28, 1997 |
| K970443 | hollister | HOLLISTER RETRACTED PENIS POUCH | February 25, 1997 |
| K963950 | bioderm | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE | January 10, 1997 |
| K931277 | hollister | HOLLISTER PREMIUM URINE COLLECTOR | June 23, 1993 |
| K924755 | convatec, a division of e.r. squibb and sons | CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION | June 22, 1993 |
| K915246 | coloplast | CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) | February 5, 1992 |
| K915616 | convatec, a division of e.r. squibb and sons | URIHESIVE STRIP | January 23, 1992 |