FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GASTROINTESTINAL CYTOLOGY BRUSH
K Number: K901435
·
Decision Jul 16, 1990
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
43
Applicant Total
22
Review Days
112
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Basic Information
- Device Name
- GASTROINTESTINAL CYTOLOGY BRUSH
- K Number
- K901435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Telemed Systems, Inc.
- Date Received
- March 26, 1990
- Decision Date
- July 16, 1990
- Product Code
- FDX
- 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 |
|---|---|---|---|
| FDX | Endoscopic Cytology Brush | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FDX), ordered by most recent decision date.
Single Use Cytology Brush V (BC-V600P-3010)
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Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
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Deflectable Brush Biopsy Set
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Brush Biopsy Set ; Deflectable Brush Biopsy Set
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Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
FDA 510(k)
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·Gastroenterology, Urology
Other Clearances by Telemed Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020379 | PPD BALLOON DILATATION CATHETER | May 6, 2002 | Substantially Equivalent |
| K013737 | MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON | Mar 1, 2002 | Substantially Equivalent |
| K010412 | FLEXIBLE ENDOSCOPIC SCISSORS | Apr 2, 2001 | Substantially Equivalent |
| K992390 | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD | Dec 22, 1999 | Substantially Equivalent |
| K992402 | 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH | Dec 22, 1999 | Substantially Equivalent |
| K974312 | REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR | Jan 21, 1998 | Substantially Equivalent |
| K974300 | TELEMED SYSTEMS RETRIEVAL BASKET | Dec 19, 1997 | Substantially Equivalent |
| K901427 | BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON | Jun 22, 1990 | Substantially Equivalent |
| K901425 | PYLORIC BALLOON DILATOR | Jun 21, 1990 | Substantially Equivalent |
| K901424 | ESOPHAGEAL BALLOON DILATOR | Jun 21, 1990 | Substantially Equivalent |