FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEDIATRIC ILLUMINATING URETERAL
K Number: K832807
·
Decision Oct 19, 1983
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
30
Applicant Total
52
Review Days
62
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
- PEDIATRIC ILLUMINATING URETERAL
- K Number
- K832807
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Van-Tec, Inc.
- Date Received
- August 18, 1983
- Decision Date
- October 19, 1983
- Product Code
- FCW
- 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 |
|---|---|---|---|
| FCW | Light Source, Fiberoptic, Routine | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCW), ordered by most recent decision date.
NOVAPROBE LED LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWER LED 175
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OVS1 VIDEO SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LED LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Van-Tec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880098 | VAN-TEC AUTO BIOPSY NEEDLE | Mar 2, 1988 | Substantially Equivalent |
| K880096 | VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP | Mar 2, 1988 | Substantially Equivalent |
| K880095 | BERGER PROSTATE CULTURE CYTOLOGY BRUSH | Mar 2, 1988 | Substantially Equivalent |
| K880099 | VAN-TEC BLADDER EVACUATOR | Mar 2, 1988 | Substantially Equivalent |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | Feb 29, 1988 | Substantially Equivalent |
| K874112 | VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER | Feb 11, 1988 | Substantially Equivalent |
| K871777 | VAN-TEC REUSABLE HELICAL STONE BASKET | Jun 17, 1987 | Substantially Equivalent |
| K871779 | HELICAL STONE BASKET (DISPOSABLE) | Jun 17, 1987 | Substantially Equivalent |
| K870679 | VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE | Mar 30, 1987 | Substantially Equivalent |
| K870557 | VAN-TEC PUMPING SYSTEM | Mar 30, 1987 | Substantially Equivalent |