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MRH — Pump, Infusion, Ophthalmic Class II

FDA Device Classification

FDA product code MRH covers "Pump, Infusion, Ophthalmic", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 19 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MRH
Device Class
Class II
Regulation Number
880.5725
Submission Type
Review Panel
OP
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243503new world medicalVIA360™ Surgical SystemFebruary 14, 2025
K232214sight sciencesOMNI Surgical SystemAugust 25, 2023
K213173microsurgical technologiesTrabEx ProJune 8, 2022
K212797glaukosiPrime Viscodelivery SystemJanuary 6, 2022
K211680new world medicalStreamline Surgical SystemOctober 8, 2021
K202678sight sciencesOMNI Surgical SystemMarch 1, 2021
K201953sight sciencesOMNI PLUS Surgical SystemAugust 11, 2020
K173332sight sciencesOMNI Surgical SystemDecember 21, 2017
K171905sight sciencesVISCO 360 Viscosurgical SystemJuly 27, 2017
K143205sight sciencesViscoelastic InjectorDecember 5, 2014
K132494sight sciencesVISCOELASTIC INJECTOROctober 22, 2013
K050716iscience surgical corporationISCIENCE SURGICAL VISCOINJECTORApril 21, 2005
K000420retinalabs.comSILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003May 8, 2000
K993039bausch and lombVISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)January 7, 2000
K981907peregrine surgicalV.F.I.-VISCOUS FLUID INFUSION TUBING SETAugust 4, 1998
K974253scieran technologiesCPD COMMANDERFebruary 25, 1998
K972664storz instrumentSTORZ MILLENNIUM VISCOUS FLUID SYSTEMOctober 10, 1997
K971067medical instrument development laboratoriesDIGI-INJECTORSeptember 19, 1997
K963434escalon trek medicalVISCOUS FLUID SYSTEMNovember 25, 1996

FDA data resources