FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
K Number: K963950
·
Decision Jan 10, 1997
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
6
Applicant Total
14
Review Days
100
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Basic Information
- Device Name
- BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
- K Number
- K963950
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioderm, Inc.
- Date Received
- October 2, 1996
- Decision Date
- January 10, 1997
- Product Code
- EXI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EXI | Device, Paste-On For Incontinence, Sterile | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXI), ordered by most recent decision date.
FEMALE EXTERNAL URINARY COLLECTION POUCH
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FDA Class 1
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HOLLISTER RETRACTED PENIS POUCH
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·Gastroenterology, Urology
HOLLISTER PREMIUM URINE COLLECTOR
FDA 510(k)
FDA Class 1
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CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
URIHESIVE STRIP
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Bioderm, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990955 | MODIFICATION OF:BIODERM FOAM WOUND DRESSING | May 18, 1999 | Substantially Equivalent |
| K982778 | BIODERM FOAM WOUND DRESSING | Oct 21, 1998 | Substantially Equivalent |
| K982939 | BTF THIN FILM WOUND DRESSING | Oct 13, 1998 | Substantially Equivalent |
| K980451 | BIODERM CALCIUM ALGINATE DRESSING | Apr 9, 1998 | Substantially Equivalent for Some Indications |
| K973429 | BIODERM FOAM WOUND DRESSING | Dec 1, 1997 | Substantially Equivalent for Some Indications |
| K963602 | BIODERM PVP FOAM WOUND DRESSING | Oct 30, 1996 | Substantially Equivalent |
| K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | Jun 21, 1995 | Substantially Equivalent |
| K951842 | BIODERM MEDICAL TRANSPARENT FILM DRESSING | Jun 12, 1995 | Substantially Equivalent |
| K950685 | BIODERM MEDICAL HYDROCOLLOID WOUND DRESSING | Jun 9, 1995 | Substantially Equivalent |
| K950619 | BIODERM MEDICAL FOAM WOUND DRESSING | Apr 25, 1995 | Substantially Equivalent |