Medical Device Manufacturer · US , Melville , NY

Olympus Optical Co., Ltd. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2000
22
Total
22
Cleared
0
Denied

Olympus Optical Co., Ltd. is a global medical device manufacturer headquartered in Melville, US. The company specializes in endoscopic and surgical imaging technologies for minimally invasive procedures.

Olympus received 22 FDA 510(k) clearances from 22 total submissions between 2000 and 2003. The company's cleared devices span multiple surgical specialties, with particular strength in endoscopic visualization systems for gastroenterology, urology, otolaryngology, and general surgery. Notable cleared products include bronchofiberscopes, gastrovideoscopes, cystofiberscopes, and electrosurgical systems.

This regulatory record represents a historical profile. Olympus has not received FDA 510(k) clearances in more than two decades and should be treated as an inactive submission record. For current product information and regulatory status, consult Olympus's official medical device channels.

Explore the complete list of cleared device names, product codes, and clearance dates in the full regulatory database record.

FDA 510(k) Regulatory Record - Olympus Optical Co., Ltd.
22 devices
1-22 of 22
Cleared Oct 16, 2003
EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND...
K033225 · EOQ
Ear, Nose, Throat · 10d
Cleared Sep 23, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031305 · LFL
General & Plastic Surgery · 152d
Cleared Jul 24, 2003
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K031648 · EOB
Ear, Nose, Throat · 57d
Cleared Jul 16, 2003
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
K032092 · FCL
Gastroenterology & Urology · 9d
Cleared May 09, 2003
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
K031347 · ODG
Radiology · 10d
Cleared Mar 12, 2003
HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE
K024138 · GEI
General & Plastic Surgery · 86d
Cleared Feb 11, 2003
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES
K021852 · GEI
General & Plastic Surgery · 251d
Cleared Jan 24, 2003
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
K022445 · HIH
Obstetrics & Gynecology · 183d
Cleared Dec 20, 2002
XTJF-160AF DUODENOVIDEOSCOPE
K024033 · FDT
Gastroenterology & Urology · 14d
Cleared Dec 19, 2002
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
K023280 · GEI
General & Plastic Surgery · 79d
Cleared Aug 20, 2002
MSS-28CS-301/701 NEEDLESCOPE
K013759 · GWG
Neurology · 280d
Cleared Aug 14, 2002
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
K022270 · ODA
Radiology · 30d
Cleared Jul 05, 2002
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
K021179 · OCY
Gastroenterology & Urology · 81d
Cleared Jun 25, 2002
UHI-3 HIGH FLOW INSUFFLATION UNIT
K014166 · HIF
Obstetrics & Gynecology · 188d
Cleared Jun 19, 2002
OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC...
K021886 · FDS
Radiology · 12d
Cleared May 01, 2002
OLYMPUS BF TYPE UM40
K021204 · PSV
Radiology · 15d
Cleared Jan 30, 2002
LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS
K013617 · GCJ
General & Plastic Surgery · 86d
Cleared Dec 26, 2001
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
K013591 · EOB
Ear, Nose, Throat · 57d
Cleared Aug 10, 2001
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
K011484 · FBK
Gastroenterology & Urology · 88d
Cleared Mar 15, 2001
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
K010591 · ODG
Radiology · 15d
Cleared Jan 30, 2001
LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY...
K002231 · FDS
Gastroenterology & Urology · 190d
Cleared Sep 08, 2000
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE
K001766 · FDS
Gastroenterology & Urology · 88d
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