FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAKE FOLEY CATHETERIZATION TRAY
K Number: K883610
·
Decision Oct 12, 1988
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
9
Applicant Total
15
Review Days
51
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Basic Information
- Device Name
- LAKE FOLEY CATHETERIZATION TRAY
- K Number
- K883610
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Lake Medical Products, Inc.
- Date Received
- August 22, 1988
- Decision Date
- October 12, 1988
- Product Code
- FCN
- 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 |
|---|---|---|---|
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCN), ordered by most recent decision date.
STANDARD FOLEY SYSTEM PAK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CATCO URINARY COLLECTION KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROCYCLER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FEMALE URINE SAMPLING DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DOUBLE CLOSED URINARY DRAINAGE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Lake Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943162 | LAKE STAGEZERO(TM) AIR FLOTATION BED | Feb 27, 1995 | Substantially Equivalent |
| K922730 | LAKE OSTOMY CARE SET | Dec 30, 1993 | Unknown |
| K905053 | STAGE ZERO AIR FLOTATION BED | Nov 26, 1990 | Substantially Equivalent |
| K901835 | LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR) | Sep 5, 1990 | Substantially Equivalent |
| K902508 | LAKE MALE EXTERNAL CATHETERIZATION KIT | Aug 23, 1990 | Unknown |
| K902121 | LAKE GASTROSTOMY TUBE | Jul 27, 1990 | Substantially Equivalent |
| K884127 | LAKE N/G FEEDING TUBE | Feb 8, 1989 | Substantially Equivalent |
| K884128 | LAKE N/G EXTENSION SET | Dec 8, 1988 | Substantially Equivalent |
| K880578 | LAKE DISPOSABLE PROBE COVER | Mar 31, 1988 | Substantially Equivalent |
| K875383 | LAKE CATHETER CARE KITS (MODIFICATION) | Mar 9, 1988 | Unknown |