FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DEFLECTING CYTOLOGY BRUSH
K Number: K822490
·
Decision Sep 14, 1982
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
6
Applicant Total
52
Review Days
27
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Basic Information
- Device Name
- DEFLECTING CYTOLOGY BRUSH
- K Number
- K822490
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Van-Tec, Inc.
- Date Received
- August 18, 1982
- Decision Date
- September 14, 1982
- Product Code
- GEE
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEE | Brush, Biopsy, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEE), ordered by most recent decision date.
STERILE SOFT TISSUE BIOPSY NEEDLE
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TROTEX II SCREW NEEDLE BIOPSY INSTR. SET
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FDA Class 1
·General, Plastic Surgery
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 |