FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROTECTIVE PAD FOR INCONTINENCE
K Number: K853079
·
Decision Aug 9, 1985
Classifications
1
FEI Numbers
417
Registration Numbers
418
Same Product Code
55
Applicant Total
9
Review Days
17
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PROTECTIVE PAD FOR INCONTINENCE
- K Number
- K853079
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5920
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- I.C.D. Industries, Inc.
- Date Received
- July 23, 1985
- Decision Date
- August 9, 1985
- Product Code
- EYQ
- 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 |
|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EYQ), ordered by most recent decision date.
DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
KIT PAK INCONTINENT SKIN CARE KIT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
DEODORIZING AND SOUND MUFFLING ANAL PAD
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
LIB SYSTEM, BABY/ADULT DIAPER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
INTERA SHIELD AND INTERA UNDERGARMENT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
DRIPRIDE PROVIDE SLIM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by I.C.D. Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K860294 | HOSPITAL TABBED NAPKINS SUPER BELTED FEMININE NAPK | Mar 13, 1986 | Substantially Equivalent |
| K844975 | SCENTED BREATHABLE MINI-SHIELD PRIVATE LABEL BRAND | Feb 25, 1985 | Substantially Equivalent |
| K843886 | SCENTED BREATHABLE PRIVATE LABEL MINI-SH | Oct 25, 1984 | Substantially Equivalent |
| K843602 | BREATHABLE MINI-SHIELD-PRIVATE LABEL | Oct 5, 1984 | Substantially Equivalent |
| K820288 | MINI SHIELDS MENSTRUAL PADS | Mar 5, 1982 | Substantially Equivalent |
| K820287 | MAXI SHIELDS MENSTRUAL PADS | Mar 5, 1982 | Substantially Equivalent |
| K813251 | UNSCENTED MENSTRUAL PADS-MAXI PADS | Dec 14, 1981 | Substantially Equivalent |
| K813252 | UNSCENTED MENSTRUAL PADS-MINI PADS | Dec 14, 1981 | Substantially Equivalent |