FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYTOLOGY BRUSH
K Number: K914504
·
Decision Feb 18, 1992
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
43
Applicant Total
11
Review Days
132
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Basic Information
- Device Name
- CYTOLOGY BRUSH
- K Number
- K914504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgitek Medical Engineering Corp.
- Date Received
- October 9, 1991
- Decision Date
- February 18, 1992
- 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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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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Other Clearances by Surgitek Medical Engineering Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K914495 | E.R.C.P. CATHETER | Jan 30, 1992 | Substantially Equivalent |
| K914497 | BIOPSY FORCEPS | Jan 3, 1992 | Substantially Equivalent |
| K914505 | STONE BASKET | Dec 9, 1991 | Substantially Equivalent |
| K914496 | SCLEROTHERAPY NEEDLE | Dec 5, 1991 | Substantially Equivalent |
| K914503 | GRASPING FORCEPS | Dec 5, 1991 | Substantially Equivalent |
| K913928 | SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT | Nov 19, 1991 | Substantially Equivalent |
| K913294 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT | Oct 4, 1991 | Substantially Equivalent |
| K910769 | SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM | Jun 25, 1991 | Substantially Equivalent |
| K910768 | SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE | Mar 19, 1991 | Substantially Equivalent |
| K903127 | SURGITEK(R) TURP MONITOR | Oct 9, 1990 | Substantially Equivalent |