FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URETERAL DILATOR/SHEATH SET
K Number: K852793
·
Decision Aug 9, 1985
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
55
Applicant Total
89
Review Days
39
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- URETERAL DILATOR/SHEATH SET
- K Number
- K852793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5470
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Edwards Laboratories
- Date Received
- July 1, 1985
- Decision Date
- August 9, 1985
- Product Code
- EZN
- 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 |
|---|---|---|---|
| EZN | Dilator, Catheter, Ureteral | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EZN), ordered by most recent decision date.
Optilume® High Pressure Urological Balloon Dilation Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
In-Ka Ureteral Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EQUINOX Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ureteral Dilator Sets, Ureteral Dilators
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Safety Wire Guide Introducer
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by American Edwards Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K873485 | EDSLAB (R) OCCLUSION BALLOON CATHETER | Dec 3, 1987 | Substantially Equivalent |
| K872596 | TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 | Sep 30, 1987 | Substantially Equivalent |
| K872529 | THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 | Sep 15, 1987 | Substantially Equivalent |
| K870444 | HOMEPRO II VOLUMETRIC INFUSION PUMP | Apr 17, 1987 | Substantially Equivalent |
| K864997 | MEDTRAC VP VOLUMETRIC INFUSION PUMP | Feb 27, 1987 | Substantially Equivalent |
| K864330 | SHEAR FORCE GAUGE | Jan 6, 1987 | Substantially Equivalent |
| K862724 | VEIN VALVE CUTTER | Jan 2, 1987 | Substantially Equivalent |
| K864155 | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS | Nov 20, 1986 | Substantially Equivalent |
| K863596 | CHIN-FOGARTY INFLATION DEVICE | Nov 20, 1986 | Substantially Equivalent |
| K863986 | XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES | Oct 31, 1986 | Substantially Equivalent |