FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES
K Number: K863986
·
Decision Oct 31, 1986
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
669
Applicant Total
89
Review Days
17
Basic Information
- Device Name
- XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES
- K Number
- K863986
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN EDWARDS LABORATORIES
- Date Received
- October 14, 1986
- Decision Date
- October 31, 1986
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRX), ordered by most recent decision date.
Arthrex Spine Endoscope
FDA 510(k)
FDA Class 2
·Orthopedic
VECTR Video Endoscopic Carpal Tunnel Release System
FDA 510(k)
FDA Class 2
·Orthopedic
MIDASVu
FDA 510(k)
FDA Class 2
·Orthopedic
Vertos mild Device Kit (MDK-0002)
FDA 510(k)
FDA Class 2
·Orthopedic
Digital ClarusScope System; Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Orthopedic
FMS VUE Fluid Management and Tissue Debridement System
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K863596 | CHIN-FOGARTY INFLATION DEVICE | Nov 20, 1986 | Substantially Equivalent |
| K864155 | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS | Nov 20, 1986 | Substantially Equivalent |
| K862872 | FLEXIBLE VISUALIZATION CATHETER | Oct 24, 1986 | Substantially Equivalent |