Olympus Medical Systems Corp. - FDA 510(k) Cleared Devices

Cleared Mar 29, 2018

OLYMPUS URF-P6/P6R

K172298 · FGB

Gastroenterology & Urology · 241d

Cleared Mar 13, 2018

Olympus Small Intestinal Capsule Endoscope System

K173459 · NEZ

Gastroenterology & Urology · 126d

Cleared Dec 07, 2017

Single Use Electrosurgical Snare SD-400

K172734 · FDI

Gastroenterology & Urology · 87d

Cleared Nov 27, 2017

Single Use Retrieval Nitinol Basket V

K170811 · LQR

Gastroenterology & Urology · 255d

Cleared Nov 17, 2017

Single Use Electrosurgical knife

K171158 · KNS

Gastroenterology & Urology · 211d

Cleared Oct 17, 2017

4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS...

K172817 · FET

Gastroenterology & Urology · 29d

Cleared Oct 13, 2017

Single Use Hot Biopsy Forceps FD-231

K171916 · KGE

Gastroenterology & Urology · 109d

Cleared Jan 19, 2017

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

K163069 · NEZ

Gastroenterology & Urology · 78d

Cleared Mar 22, 2016

Single Use Aspiration Needle NA-U401SX

K160098 · FCG

Gastroenterology & Urology · 63d

Cleared Mar 02, 2016

Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215

K160241 · KNS

Gastroenterology & Urology · 30d

Cleared Feb 12, 2016

Single Use Injector NM600/610

K153625 · FBK

Gastroenterology & Urology · 56d

Cleared Jan 15, 2016

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V

K143153 · FDT

Gastroenterology & Urology · 438d

Cleared Nov 20, 2015

Single Use Aspiration Needle NA-U200H

K151738 · FCG

Gastroenterology & Urology · 147d

Cleared Oct 08, 2015

Single Use Balloon Dilator V (with Knife)

K150142 · KNS

Gastroenterology & Urology · 259d

Cleared Feb 27, 2015

Single Use Biliary Balloon Dilator

K143303 · FGE

Gastroenterology & Urology · 101d

Cleared Feb 08, 2015

ENDOCAPSULE SOFTWARE 10

K142680 · NEZ

Gastroenterology & Urology · 142d

Cleared Mar 07, 2014

ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT

K134026 · PGU

Gastroenterology & Urology · 67d

Cleared Aug 29, 2013

EVIS EXERA III VIDEO SYSTEM

K131780 · FDF

Gastroenterology & Urology · 73d

Cleared Apr 29, 2013

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

K123421 · NEZ

Gastroenterology & Urology · 174d

Cleared Apr 29, 2013

SINGLE USE REPOSITIONABLE CLIP

K123601 · PKL

Gastroenterology & Urology · 159d

Cleared Apr 11, 2013

SINGLE USE PRELOADED SPHINCTEROTOME V

K122505 · KNS

Gastroenterology & Urology · 238d

Cleared Feb 04, 2013

AUTOMATED ENDOSCOPE LEAK TESTER

K123704 · PCV

Gastroenterology & Urology · 63d

Cleared Dec 14, 2012

VIDEO SYSTEM CENTER

K122831 · NTN

Gastroenterology & Urology · 88d

Cleared Sep 25, 2012

CHF-Y0005

K113120 · FBN

Gastroenterology & Urology · 340d

Cleared Mar 20, 2012

V1 SYSTEM

K111756 · FDF

Gastroenterology & Urology · 272d