Product code FSW— General, Plastic Surgery
CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
- Classification name
- Light, Surgical, Endoscopic
- Device class
- Class 2
- Regulation
- 21 CFR 878.4580
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code FSW
FDA has cleared devices under product code FSW between 1987 and 2002, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2002
- 1994
- 1993
- 1992
- 1991
- 1989
- 1987
Top applicants under product code FSW
Recent clearances under product code FSW
- K022989 — RADLITE TISSUE RETRACTOR SYSTEM
- K013511 — XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)
- K943342 — MEDICAM XENON LIGHT SOURCE
- K934337 — CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
- K922279 — ILLUMINATOR IV MINOR SURGERY LIGHT
- K913135 — LM-300TWIN
- K894319 — MEDICAL DYNAMICS LIGHT SOURCE
- K870898 — ULTRA-LUX LIGHT SOURCE
Data sourced from openFDA. This site is unofficial and independent of the FDA.