FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UROLOGICAL BIOPSY BRUSH SET
K Number: K770913
·
Decision Jun 1, 1977
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
43
Applicant Total
190
Review Days
13
Basic Information
- Device Name
- UROLOGICAL BIOPSY BRUSH SET
- K Number
- K770913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cook, Inc.
- Date Received
- May 19, 1977
- Decision Date
- June 1, 1977
- 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 Cook, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133130 | BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER | Jan 9, 2015 | Substantially Equivalent |
| K140593 | ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE | Dec 15, 2014 | Substantially Equivalent |
| K132592 | FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET | Oct 9, 2014 | Substantially Equivalent |
| K133597 | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY | Apr 18, 2014 | Substantially Equivalent |
| K131772 | CANTATA(R) 2.9 MICROCATHETER | Feb 20, 2014 | Substantially Equivalent |
| K131204 | ADVANCE CS CORONARY SINUS INFUSION CATHETER | Jan 29, 2014 | Substantially Equivalent |
| K133634 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET | Dec 23, 2013 | Substantially Equivalent |
| K132020 | ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER | Oct 25, 2013 | Substantially Equivalent |
| K131201 | ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET | Oct 7, 2013 | Substantially Equivalent |
| K131206 | COOK CERVICAL RIPENING BALLOON | Sep 27, 2013 | Substantially Equivalent |