FDA 510(k) Applications for Medical Device Product Code "MRH"
(Pump, Infusion, Ophthalmic)

FDA 510(k) Number Applicant Device Name Decision Date
K993039 BAUSCH & LOMB, INC. VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) 01/07/2000
K963434 ESCALON TREK MEDICAL VISCOUS FLUID SYSTEM 11/25/1996
K212797 Glaukos iPrime Viscodelivery System 01/06/2022
K050716 ISCIENCE SURGICAL CORPORATION ISCIENCE SURGICAL VISCOINJECTOR 04/21/2005
K971067 MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. DIGI-INJECTOR 09/19/1997
K213173 MicroSurgical Technologies Inc TrabEx Pro 06/08/2022
K211680 New World Medical, Inc. Streamline Surgical System 10/08/2021
K981907 PEREGRINE SURGICAL LTD. V.F.I.-VISCOUS FLUID INFUSION TUBING SET 08/04/1998
K000420 RETINALABS.COM SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 05/08/2000
K974253 SCIERAN TECHNOLOGIES, INC. CPD COMMANDER 02/25/1998
K232214 Sight Sciences Inc., OMNI Surgical System 08/25/2023
K201953 Sight Sciences, Inc. OMNI PLUS Surgical System 08/11/2020
K173332 Sight Sciences, Inc. OMNI Surgical System 12/21/2017
K202678 Sight Sciences, Inc. OMNI Surgical System 03/01/2021
K171905 Sight Sciences, Inc. VISCO 360 Viscosurgical System 07/27/2017
K143205 Sight Sciences, Inc. Viscoelastic Injector 12/05/2014
K132494 SIGHT SCIENCES, INC. VISCOELASTIC INJECTOR 10/22/2013
K972664 STORZ INSTRUMENT CO. STORZ MILLENNIUM VISCOUS FLUID SYSTEM 10/10/1997


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