FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CO2 LASER BRONCHOSCOPE COUPLER
K Number: K894962
·
Decision Sep 28, 1989
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
17
Review Days
52
Basic Information
- Device Name
- CO2 LASER BRONCHOSCOPE COUPLER
- K Number
- K894962
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- CUDA PRODUCTS CO.
- Date Received
- August 7, 1989
- Decision Date
- September 28, 1989
- 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 CUDA PRODUCTS CO.
| K Number | Device Name | ||
|---|---|---|---|
| K983277 | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 | Dec 16, 1998 | Substantially Equivalent |
| K981962 | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | Aug 18, 1998 | Substantially Equivalent |
| K981469 | CERMAX300 LIGHTSOURCE | Jul 9, 1998 | Substantially Equivalent |
| K980350 | VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 | Apr 28, 1998 | Substantially Equivalent |
| K980166 | LIGHTSOURCE OR ILLUMINATOR | Apr 1, 1998 | Substantially Equivalent |
| K961074 | LIGHTSOURCE OR ILLUMINATOR | Apr 30, 1996 | Substantially Equivalent |
| K951019 | INTRAORAL VIDEO SCOPE AND WINDOW TUBE | May 10, 1995 | Substantially Equivalent |
| K943731 | VIDEO OTOSCOPE | Oct 11, 1994 | Substantially Equivalent |
| K935818 | ENDOSCOPE | Jul 13, 1994 | Substantially Equivalent |
| K933369 | CUDA PRODUCTS CORP. LIGHTSOURCES | Jan 3, 1994 | Substantially Equivalent |