FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYTOLOGY BRUSH
K Number: K913248
·
Decision Sep 30, 1991
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
43
Applicant Total
23
Review Days
70
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Basic Information
- Device Name
- CYTOLOGY BRUSH
- K Number
- K913248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Annex Medical, Inc.
- Date Received
- July 22, 1991
- Decision Date
- September 30, 1991
- 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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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 Annex Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954377 | FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC | Oct 26, 1995 | Substantially Equivalent |
| K952863 | FORCEPS, BIOPSY, NON-ELECTRIC | Jul 19, 1995 | Substantially Equivalent |
| K951532 | METAL URETERAL BASKET STONE DISLODGER | Jul 19, 1995 | Substantially Equivalent |
| K951761 | METEL URETERAL BASKET STONE DISLODGER | May 11, 1995 | Substantially Equivalent |
| K934636 | ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR | Feb 25, 1994 | Substantially Equivalent |
| K934675 | METAL URETERAL BASKET STONE DISLODGER | Jan 7, 1994 | Substantially Equivalent |
| K934598 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | Jan 7, 1994 | Substantially Equivalent |
| K925267 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | Feb 10, 1993 | Substantially Equivalent |
| K925559 | BILIARY STONE DISLODGER | Dec 17, 1992 | Substantially Equivalent |
| K921401 | BIOPSY FORCEPS | Oct 21, 1992 | Substantially Equivalent |