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510(k) K221872

Device
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System
Applicant
Nova Eye Inc. (Business Name Nova Eye Medical)
510(k) number
K221872
Product code
MPA
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-30
Date received
2022-06-28
Regulation
876.1500
Classification name
Endoilluminator
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Don Watton
Address
41316 Christy St. Fremont CA US 94538 94538

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MPA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc.2024-12-04
K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)Peregrine Surgical, LLC2024-08-05
K202670Nam illumination probe with chopperOculight , Ltd.2021-08-20
K15160423ga Chandelier Illuminator, 25ga Chandelier IlluminatorPeregrine Surgical , Ltd.2015-09-11
K143123Synergetics PHOTON EXSynergetics2015-02-24
K080067ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETERIscience Interventional2008-07-18
K062895XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIIIDutch Ophthalmic Research Center International BV2006-10-13
K062259ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100Iscience Surgical2006-08-15
K041108ISCIENCE SURGICAL OPHTHALMIC MICROCANNULAIscience Surgical Corporation2004-06-22
K032598SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCESynergetics, Inc.2003-11-24
K000252INSIGHT 4000 ENDOSCOPEInsight Instruments Mfg., Inc.2000-10-17
K000416TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001Retinalabs.Com2000-05-08
K980797PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATORPeregrine Surgical , Ltd.1998-05-19
K980530PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13Peregrine Surgical , Ltd.1998-05-12
K980025PEREGRINE TAPERED DIFFUSION PROBEPeregrine Surgical , Ltd.1998-03-31