MSR — Tubing, Replacement, Phacofragmentation Unit Class II

FDA Device Classification

FDA product code MSR covers "Tubing, Replacement, Phacofragmentation Unit", a Class II medical device regulated under 21 CFR 886.4150. Submissions are reviewed by the Ophthalmic panel. At least 5 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MSR
Device Class
Class II
Regulation Number
886.4150
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K993361hurricane medicalTUBING EXTENSION SETJanuary 4, 2000
K983448med-logicsML UNIVERSAL TUBINGDecember 18, 1998
K980849surgin surgical instrumentationSURGIN KITJuly 9, 1998
K980100storz instrumentSTORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACKJune 1, 1998
K972522med-logicsML-DISPOSABLE PAKSeptember 30, 1997