FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES
K Number: K920659
·
Decision Jun 5, 1992
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
48
Review Days
114
Basic Information
- Device Name
- DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES
- K Number
- K920659
- 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
- DAVOL, INC.
- Date Received
- February 12, 1992
- Decision Date
- June 5, 1992
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
AviClear Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pastelle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SurgiLight 1470 Diode Laser System (Model:Halo)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AuroLase® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Diode laser device (RF3120-BI)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by DAVOL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K031213 | AQUASENS FLUID MONITORING SYSTEM | Apr 30, 2003 | Substantially Equivalent |
| K030307 | DAVOL ARTHROVENT OUTFLOW TUBING | Feb 13, 2003 | Substantially Equivalent |
| K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 | Jan 22, 2001 | Substantially Equivalent |
| K003790 | DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 | Dec 22, 2000 | Substantially Equivalent |
| K931899 | DAVOL ATS | Nov 15, 1994 | Substantially Equivalent |
| K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE | Jun 14, 1994 | Substantially Equivalent |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | Mar 25, 1994 | Substantially Equivalent |
| K935503 | DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET | Mar 7, 1994 | Substantially Equivalent |
| K926479 | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM | Mar 1, 1994 | Substantially Equivalent |
| K931552 | DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT | Oct 8, 1993 | Substantially Equivalent |