NCR — Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered Class II

FDA Device Classification

FDA product code NCR covers "Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered", a Class II medical device regulated under 21 CFR 886.4100. Submissions are reviewed by the Ophthalmic panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
NCR
Device Class
Class II
Regulation Number
886.4100
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K050933medisurgFUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300December 9, 2005
K041019medisurgTHE FUGO BLADE FOR GLAUCOMAOctober 8, 2004
K001498medisurgTHE FUGO BLADEAugust 10, 2000