FDA Product Code
FDA Product Code EXI — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5250
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K971499 | FEMALE EXTERNAL URINARY COLLECTION POUCH | Mediquest, Inc. | 1997-08-28 | Traditional | PDF ↗ |
| K970443 | HOLLISTER RETRACTED PENIS POUCH | Hollister, Inc. | 1997-02-25 | Traditional | PDF ↗ |
| K963950 | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE | Bioderm, Inc. | 1997-01-10 | Traditional | PDF ↗ |
| K931277 | HOLLISTER PREMIUM URINE COLLECTOR | Hollister, Inc. | 1993-06-23 | Traditional | PDF ↗ |
| K924755 | CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION | Convatec, A Division of E.R. Squibb & Sons | 1993-06-22 | Traditional | PDF ↗ |
| K915246 | CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) | Coloplast A/S | 1992-02-05 | Traditional | PDF ↗ |
| K915616 | URIHESIVE STRIP | Convatec, A Division of E.R. Squibb & Sons | 1992-01-23 | Traditional | PDF ↗ |
Product code EXI · Class I · Gastroenterology, Urology. Data: openFDA.