Product code MPA

Device name: Endoilluminator
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation number: 876.1500
Review panel: OP
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K242184	Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);	Alcon Laboratories, Inc.	2024-12-04
K233653	Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)	Peregrine Surgical, LLC	2024-08-05
K221872	ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System	Nova Eye Inc. (Business Name Nova Eye Medical)	2023-03-30
K202670	Nam illumination probe with chopper	Oculight , Ltd.	2021-08-20
K151604	23ga Chandelier Illuminator, 25ga Chandelier Illuminator	Peregrine Surgical , Ltd.	2015-09-11
K143123	Synergetics PHOTON EX	Synergetics	2015-02-24
K080067	ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER	Iscience Interventional	2008-07-18
K062895	XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII	Dutch Ophthalmic Research Center International BV	2006-10-13
K062259	ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100	Iscience Surgical	2006-08-15
K041108	ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA	Iscience Surgical Corporation	2004-06-22
K032598	SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE	Synergetics, Inc.	2003-11-24
K000252	INSIGHT 4000 ENDOSCOPE	Insight Instruments Mfg., Inc.	2000-10-17
K000416	TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001	Retinalabs.Com	2000-05-08
K980797	PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR	Peregrine Surgical , Ltd.	1998-05-19
K980530	PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13	Peregrine Surgical , Ltd.	1998-05-12
K980025	PEREGRINE TAPERED DIFFUSION PROBE	Peregrine Surgical , Ltd.	1998-03-31
K980027	PEREGRINE SHIELDED DIFFUSION PROBE	Peregrine Surgical , Ltd.	1998-03-31
K973229	D.O.R.C. HEXON ILLUMINATION SYSTEM	Dutch Ophthalmic USA, Inc.	1997-11-25
K973293	SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR	Vaughan Weeks	1997-11-18
K973290	SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK	Vaughan Weeks	1997-11-14
K973757	D.O.R.C. SOLUX LIGHT SOURCE	Dutch Ophthalmic USA, Inc.	1997-11-07
K971679	I-SCOPE OPHTHALMIC ENDOSCOPE	Ophthalmic Technologies, Inc.	1997-06-25
K970882	ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)	American Medical Devices, Inc.	1997-06-24
K964005	SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE	Synergetics, Inc.	1997-06-09
K970875	ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)	American Medical Devices, Inc.	1997-05-20
K964405	MBI ILLUMINATED RETINAL PICK	M.B. Industries, Inc.	1997-05-13
K964553	MBI CO-AXIAL ILLUMINATED RETINAL PICK	M.B. Industries, Inc.	1997-05-13
K970878	ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT	American Medical Devices, Inc.	1997-05-06
K971338	SYNTEC, INC. DISPOSABLE BARE END FIBER	Syntec, Inc.	1997-05-06
K964555	VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)	Vitrotec, Inc.	1997-03-31

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
08717872035543	TotalView Chandelier for cannula system.(25 gauge / 0.5 mm)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-04-01
08717872035499	TotalView Endoillumination Probe, with 2 exchangeable tips.(23 gauge / 0.6 mm)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-04-01
08717872035529	Eckardt TwinLight Chandelier with Photon connector and guidance needle.(27 gauge	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-03-31
08717872035512	Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-03-31
08717872035505	TotalView Endoillumination Probe, including illuminated scleral depressor.(20 ga	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-03-31
08717872035482	Endoillumination Probe, including illuminated scleral depressor.(23 gauge / 0.6	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-03-31
08717872035475	Endoillumination Probe, including illuminated scleral depressor.(25 gauge / 0.5	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-03-31
08717872035468	TotalView Endoillumination Probe, including illuminated scleral depressor.(25 ga	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-03-31
08717872035451	TotalView Endoillumination Probe, including illuminated scleral depressor.(23 ga	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-03-31
08717872035444	Shielded TotalView Endoillumination Probe, including illuminated scleral depress	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-03-31
08717872035420	23 GA./0.6mm Shielded TotalView Endo. Probe, including ill. scleral depressor	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-03-31
08717872035406	Endoillumination Probe, including illuminated scleral depressor.(20 gauge / 0.9	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2025-03-31
08717872009520	Disposable Eckardt Twinlight Chandelier. (27 gauge / 0.4mm)	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	2022-10-04
10840096213956	25ga Illuminated MultiFlex™ Laser Probe, DORC Connector	KATALYST SURGICAL LLC	2021-01-07
00840096208283	Constellation Illumination Adapter	KATALYST SURGICAL LLC	2020-06-10
00840096208313	Short 19ga Needle Illumination Adapter	KATALYST SURGICAL LLC	2020-06-10
00840096208306	DORC Illumination Adapter	KATALYST SURGICAL LLC	2020-06-10
00840096208290	Stellaris Illumination Adapter	KATALYST SURGICAL LLC	2020-06-10
00840096208276	Revolver Universal Connector	KATALYST SURGICAL LLC	2020-06-08
10817489027773	27ga Stiff Illuminated MultiFlex™ Inverted Extendable Laser Probe, Iridex Connec	KATALYST SURGICAL LLC	2019-04-03
10817489027766	25ga Stiff Illuminated MultiFlex™ Inverted Extendable Laser Probe, Iridex Connec	KATALYST SURGICAL LLC	2019-04-03
10817489027759	23ga Illuminated MultiFlex™ Inverted Extendable Laser Probe, Iridex Connector	KATALYST SURGICAL LLC	2019-04-03
10817489027742	27ga Stiff Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector	KATALYST SURGICAL LLC	2019-04-03
10817489027735	25ga Stiff Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector	KATALYST SURGICAL LLC	2019-04-03
10817489027728	23ga Illuminated MultiFlex™ Inverted Laser Probe, Iridex Connector	KATALYST SURGICAL LLC	2019-04-03
10817489027711	27ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector	KATALYST SURGICAL LLC	2019-04-03
10817489027704	25ga Stiff Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector	KATALYST SURGICAL LLC	2019-04-03
10817489027698	23ga Illuminated MultiFlex™ Extendable Laser Probe, Iridex Connector	KATALYST SURGICAL LLC	2019-04-03
10817489027681	27ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex Connector	KATALYST SURGICAL LLC	2019-04-03
10817489027674	25ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex Connector	KATALYST SURGICAL LLC	2019-04-03

Product code MPA

Related 510(k) Records#

Related GUDID Devices#