FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URETERAL DILATOR
K Number: K840746
·
Decision Apr 13, 1984
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
26
Applicant Total
89
Review Days
85
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Basic Information
- Device Name
- URETERAL DILATOR
- K Number
- K840746
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Edwards Laboratories
- Date Received
- January 19, 1984
- Decision Date
- April 13, 1984
- Product Code
- KOE
- 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 |
|---|---|---|---|
| KOE | Dilator, Urethral | FDA class 2 | Gastroenterology, Urology |
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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 |