Panels › Gastroenterology, Urology › Product code EXI · Class 1
Device, Paste-On For Incontinence, Sterile
Regulation 876.5250
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EXI
| Company | 510(k)s | Recalls |
|---|---|---|
| Convatec, A Division of E.R. Squibb & Sons | 2 | 0 |
| Hollister, Inc. | 2 | 0 |
| Bioderm, Inc. | 1 | 0 |
| Coloplast A/S | 1 | 0 |
| Mediquest, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 1997 | K971499 | FEMALE EXTERNAL URINARY COLLECTION POUCH Mediquest, Inc. | EXI |
| Feb 25, 1997 | K970443 | HOLLISTER RETRACTED PENIS POUCH Hollister, Inc. | EXI |
| Jan 10, 1997 | K963950 | BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE Bioderm, Inc. | EXI |
| Jun 23, 1993 | K931277 | HOLLISTER PREMIUM URINE COLLECTOR Hollister, Inc. | EXI |
| Jun 22, 1993 | K924755 | CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION Convatec, A Division of E.R. Squibb & Sons | EXI |
| Feb 5, 1992 | K915246 | CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) Coloplast A/S | EXI |
| Jan 23, 1992 | K915616 | URIHESIVE STRIP Convatec, A Division of E.R. Squibb & Sons | EXI |
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