FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMCATH DISPOSABLE CYTOLOGY BRUSH
K Number: K923200
·
Decision Dec 7, 1992
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
43
Applicant Total
17
Review Days
160
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Basic Information
- Device Name
- AMCATH DISPOSABLE CYTOLOGY BRUSH
- K Number
- K923200
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intl. Medical, Inc.
- Date Received
- June 30, 1992
- Decision Date
- December 7, 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.
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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 Intl. Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970507 | PEAK FLOW METER | Jun 13, 1997 | Substantially Equivalent |
| K943078 | HOT BIOPSY FORCEPS | Nov 14, 1994 | Substantially Equivalent |
| K940370 | AMERICAN CATHETER E.R.C.P. CANNULA | Aug 17, 1994 | Substantially Equivalent |
| K940335 | AMERICAN CATHETER POLY-SNARE | Jul 21, 1994 | Substantially Equivalent |
| K942068 | AMERICAN CATHETER SPHINCTEROTOME | Jun 24, 1994 | Substantially Equivalent |
| K930406 | DURHAM; MIN BORE LUER LOCK EXTENSION SET | Sep 3, 1993 | Substantially Equivalent |
| K930410 | DURHAM; LUER LOCK EXTENSION SET | Sep 3, 1993 | Substantially Equivalent |
| K915142 | AMCATH DISPOSABLE BIOPSY FORCEPS | Jan 10, 1992 | Substantially Equivalent |
| K912927 | AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE | Sep 19, 1991 | Substantially Equivalent |
| K912605 | AMCATH DISPOSABLE MICRO SCISSORS | Jul 11, 1991 | Substantially Equivalent |