Medical Device Manufacturer · US , Melville , NY

Olympus Medical Systems Corporation - FDA 510(k) Cleared Devices

81 submissions · 81 cleared · Since 2004
81
Total
81
Cleared
0
Denied
46 devices
26-46 of 46
Cleared Mar 10, 2010
OLYMPUS CHF TYPE Y0003
K093507 · FBN
Gastroenterology & Urology · 117d
Cleared Oct 30, 2009
SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR,...
K092309 · KNS
Gastroenterology & Urology · 92d
Cleared Sep 18, 2009
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND...
K091759 · KNT
Gastroenterology & Urology · 94d
Cleared Sep 03, 2009
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V...
K091495 · LQR
Gastroenterology & Urology · 106d
Cleared Jul 29, 2009
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K090210 · NEZ
Gastroenterology & Urology · 182d
Cleared Jan 13, 2009
HD CAMERA HEAD OTV-S7PROH-HD-L08E
K083155 · FET
Gastroenterology & Urology · 81d
Cleared Nov 06, 2008
OLYMPUS CHF TYPE V
K081456 · FBN
Gastroenterology & Urology · 167d
Cleared Oct 21, 2008
XCHF-T160 VIDEOSCOPE
K082576 · FBN
Gastroenterology & Urology · 46d
Cleared May 20, 2008
XTJF TYPE Q160VF1
K080403 · FDT
Gastroenterology & Urology · 96d
Cleared May 06, 2008
OLYMPUS XCHF TYPE B180Y1
K080586 · FBN
Gastroenterology & Urology · 64d
Cleared Mar 25, 2008
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K071254 · FDA
Gastroenterology & Urology · 326d
Cleared Mar 18, 2008
EVIS EXERA II 180 SYSTEM
K072957 · NWB
Gastroenterology & Urology · 151d
Cleared Sep 14, 2007
OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K063259 · NEZ
Gastroenterology & Urology · 319d
Cleared Mar 05, 2007
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2
K063786 · FCX
Gastroenterology & Urology · 74d
Cleared Dec 22, 2006
ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES
K062517 · KGE
Gastroenterology & Urology · 116d
Cleared Sep 22, 2006
EVIS EXERA II 180 SYSTEM
K062049 · NWB
Gastroenterology & Urology · 64d
Cleared Nov 14, 2005
OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
K051886 · FBN
Gastroenterology & Urology · 125d
Cleared Oct 13, 2005
EVIS EXERA 160A SYSTEM
K051645 · NWB
Gastroenterology & Urology · 115d
Cleared Aug 15, 2005
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT...
K051613 · ODA
Gastroenterology & Urology · 59d
Cleared Jun 28, 2005
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K051551 · KNT
Gastroenterology & Urology · 15d
Cleared May 12, 2005
SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
K050503 · FCG
Gastroenterology & Urology · 73d
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