Product code NCR— Ophthalmic
FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
- Classification name
- Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
- Device class
- Class 2
- Regulation
- 21 CFR 886.4100
- Advisory panel
- Ophthalmic
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code NCR
FDA has cleared devices under product code NCR between 2000 and 2005, filed by 1 applicant company. 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
- 2005
- 2004
- 2000
Top applicants under product code NCR
Recent clearances under product code NCR
Data sourced from openFDA. This site is unofficial and independent of the FDA.