FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HORIZONS CYTOLOGY BRUSH
K Number: K021998
·
Decision Jul 12, 2002
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
43
Applicant Total
10
Review Days
23
Basic Information
- Device Name
- HORIZONS CYTOLOGY BRUSH
- K Number
- K021998
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Horizons Intl. Corp.
- Date Received
- June 19, 2002
- Decision Date
- July 12, 2002
- 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)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Cytology Brush
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Deflectable Brush Biopsy Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Brush Biopsy Set ; Deflectable Brush Biopsy Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Horizons Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K083049 | TORNADO ROTATABEL SNARE AND POLYP CATCHER | Dec 23, 2008 | Substantially Equivalent |
| K022268 | HORIZONS REUSABLE POLYPECTOMY SNARES | Oct 25, 2002 | Substantially Equivalent |
| K022243 | HORIZONS REUSABLE HOT BIOPSY FORCEPS | Oct 25, 2002 | Substantially Equivalent |
| K022546 | HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES | Aug 12, 2002 | Substantially Equivalent |
| K021706 | HORIZONS HOT BIOPSY FORCEPS | Jun 21, 2002 | Substantially Equivalent |
| K011667 | HORIZONS INTERNATIONAL POLYPECTOMY SNARES | Aug 16, 2001 | Substantially Equivalent |
| K010448 | HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES | May 16, 2001 | Substantially Equivalent |
| K002235 | HORIZONS ERCP CANNULA | Jan 23, 2001 | Substantially Equivalent |
| K002236 | HORIZONS PAPILLOTOME | Jan 23, 2001 | Substantially Equivalent |