BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
FDA 510(k) clearance K963950 · decided 1997-01-10
Clearance details
- K-number
- K963950
- Device name
- BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
- Applicant
- Bioderm, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-02
- Decision date
- 1997-01-10
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- EXI
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- East Burnswick, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FEMALE EXTERNAL URINARY COLLECTION POUCH (K971499) | Mediquest, Inc. | 1997-08-28 |
| HOLLISTER RETRACTED PENIS POUCH (K970443) | Hollister, Inc. | 1997-02-25 |
| HOLLISTER PREMIUM URINE COLLECTOR (K931277) | Hollister, Inc. | 1993-06-23 |
| CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION (K924755) | Convatec, A Division of E.R. Squibb & Sons | 1993-06-22 |
| CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) (K915246) | Coloplast A/S | 1992-02-05 |
| URIHESIVE STRIP (K915616) | Convatec, A Division of E.R. Squibb & Sons | 1992-01-23 |
Recalls involving this device
No recalls on record reference this clearance.