FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
K Number: K080525
·
Decision Apr 17, 2008
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
104
Review Days
51
Basic Information
- Device Name
- COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
- K Number
- K080525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- COOK UROLOGICAL, INC.
- Date Received
- February 26, 2008
- Decision Date
- April 17, 2008
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| K073496 | OPTILITE HOLMIUM LASER FIBERS | Jan 23, 2008 | Substantially Equivalent |
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Nov 20, 2007 | Substantially Equivalent |
| K061371 | SYDNEY IVF SPERM CRYOPRESERVATION BUFFER | Aug 17, 2006 | Substantially Equivalent |
| K060908 | SONOHYSTEROGRAPHY BIOPSY DEVICE | Jun 29, 2006 | Substantially Equivalent |