Atlas FDA

MPA

40 FDA 510(k) clearances · Product code

90 daysmedian time to decision
275 days90th percentile
40clearances measured

FDA profile

Official device name
Endoilluminator
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2010: 39 · 2011: 32 · 2012: 35 · 2013: 19 · 2014: 10 · 2024: 62
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (K242184)Alcon Laboratories, Inc.2024-12-04
Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) (K233653)Peregrine Surgical, LLC2024-08-05
ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System (K221872)Nova Eye Inc. (Business Name Nova Eye Medical)2023-03-30
Nam illumination probe with chopper (K202670)Oculight , Ltd.2021-08-20
23ga Chandelier Illuminator, 25ga Chandelier Illuminator (K151604)Peregrine Surgical , Ltd.2015-09-11
Synergetics PHOTON EX (K143123)Synergetics2015-02-24
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER (K080067)Iscience Interventional2008-07-18
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII (K062895)Dutch Ophthalmic Research Center International BV2006-10-13
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 (K062259)Iscience Surgical2006-08-15
ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA (K041108)Iscience Surgical Corporation2004-06-22
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (K032598)Synergetics, Inc.2003-11-24
INSIGHT 4000 ENDOSCOPE (K000252)Insight Instruments Mfg., Inc.2000-10-17
TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 (K000416)Retinalabs.Com2000-05-08
PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR (K980797)Peregrine Surgical , Ltd.1998-05-19
PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 (K980530)Peregrine Surgical , Ltd.1998-05-12
PEREGRINE SHIELDED DIFFUSION PROBE (K980027)Peregrine Surgical , Ltd.1998-03-31
PEREGRINE TAPERED DIFFUSION PROBE (K980025)Peregrine Surgical , Ltd.1998-03-31
D.O.R.C. HEXON ILLUMINATION SYSTEM (K973229)Dutch Ophthalmic USA, Inc.1997-11-25
SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR (K973293)Vaughan Weeks1997-11-18
SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK (K973290)Vaughan Weeks1997-11-14
D.O.R.C. SOLUX LIGHT SOURCE (K973757)Dutch Ophthalmic USA, Inc.1997-11-07
I-SCOPE OPHTHALMIC ENDOSCOPE (K971679)Ophthalmic Technologies, Inc.1997-06-25
ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) (K970882)American Medical Devices, Inc.1997-06-24
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE (K964005)Synergetics, Inc.1997-06-09
ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) (K970875)American Medical Devices, Inc.1997-05-20
MBI CO-AXIAL ILLUMINATED RETINAL PICK (K964553)M.B. Industries, Inc.1997-05-13
MBI ILLUMINATED RETINAL PICK (K964405)M.B. Industries, Inc.1997-05-13
SYNTEC, INC. DISPOSABLE BARE END FIBER (K971338)Syntec, Inc.1997-05-06
ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT (K970878)American Medical Devices, Inc.1997-05-06
VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) (K964555)Vitrotec, Inc.1997-03-31
VITLITE (TR7700) (K963417)Escalon Trek Medical1996-12-20
MBI FIBEROPTIC ENDO-ILLUMINATOR (K961036)M.B. Industries, Inc.1996-07-15
STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (K960007)Storz1996-03-26
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR (K952581)Gamp & Assoc.1996-01-05
GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR (K952585)Gamp & Assoc.1996-01-05
INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM (K951627)Infinitech, Inc.1995-10-19
INFINITECH LIGHTED INFUSION CANNULA (K946136)Surgical Technologies, Inc.1995-10-02
GAMP & ASSOCIATES DISPOSABLE BARE END FIBER (K952580)Gamp & Assoc.1995-09-01
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (K952586)Gamp & Assoc.1995-09-01
GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK (K952584)Gamp & Assoc.1995-09-01

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Every clearance here is in the API, with alerts when new ones post.