Atlas FDA

FFS

26 FDA 510(k) clearances · Product code

70 daysmedian time to decision
183 days90th percentile
26clearances measured

FDA profile

Official device name
Image, Illumination, Fiberoptic, For Endoscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2013: 10 · 2017: 19 · 2018: 19 · 2019: 17 · 2020: 56 · 2021: 57
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (K072521)Cook Urological, Inc.2007-11-20
PS SERIES (K061622)Photonic Optische Gerate Gesmbh & Cokg2007-03-05
TRU-CABLE (K063309)Truphatek International, Ltd.2007-01-12
ACCUTECH ENDOLITE PROBE (K061025)Accutech Medical Technologies, Inc.2006-05-31
SOVIS OPTIQUE'S ENDOSCOPIC CABLE (K023633)Sovis Optique2002-12-31
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (K001698)Cogent Light Technologies, Inc.2000-07-17
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (K994084)Smith & Nephew, Inc.2000-01-20
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR (K991323)Smith & Nephew, Inc.1999-07-06
SOLARTEC SOURCE 270, MODEL # 90123 (K983714)Cogent Light Technologies, Inc.1998-12-23
FIBER OPTIC ENDOILLUMINATION PROBE (K982462)Microvision, Inc.1998-09-14
FIBER OPTIC ENDOILLUMINATION PROBE (K980636)Dutch Ophthalmic USA, Inc.1998-05-20
VISTA ILLUMINATION SYSTEM (K970217)Vista Medical Technologies, Inc.1997-04-02
KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS (K962595)KARL STORZ Endoscopy-America, Inc.1996-09-04
REDDY ILLUMINATOR (K950960)Luxtec Corp.1995-09-08
MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE (K945102)Alm Surgical Equipment, Inc.1994-11-04
LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR (K944688)Progressive Dynamics, Inc.1994-11-01
XENON LIGHT SOURCE (K940963)Incredivision, Inc.1994-04-08
LIQUID LIGHT 500 (K940962)Incredivision, Inc.1994-04-08
KARL STORZ ENDOSCOPY-AMERICA, INC. (K933216)KARL STORZ Endoscopy-America, Inc.1993-09-09
FIBER OPTIC LIGHT TRANSMISSION CABLE (K892145)Opto Vision, Inc.1989-09-29
FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150 (K893440)Welch Allyn, Inc.1989-07-28
LIGHT SOURCE, ENDOSCOP, XENON ARC (K890448)Mira, Inc.1989-05-08
EFF-EFFNER BULBS (K844773)Mecron Medical Products, Inc.1985-01-08
REAL FIBER OPTIC URETERAL TRANSILLUMIN (K834576)Douglas Manufacturer Co.1984-04-20
LABORIE FIBREOPTIC LIGHT CABLE (K840605)Tridak Division of Indicon, Inc.1984-04-13
FLEXIBLE LIQUID LIGHT GUIDE (K834487)Endo Lase, Inc.1984-02-21

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