510(k) K041019
K041019 is an FDA 510(k) premarket notification submitted by Medisurg , Ltd. for the device "THE FUGO BLADE FOR GLAUCOMA". The FDA issued a decision of Substantially Equivalent on October 8, 2004. The device falls under product code NCR (Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered), a Class II device regulated under 21 CFR 886.4100. Medisurg , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2004
- Date Received
- April 20, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
- Device Class
- Class II
- Regulation Number
- 886.4100
- Review Panel
- OP
- Submission Type