Olympus Medical Systems Corp.
FDA 510(k) medical device clearances.
Top product codes for Olympus Medical Systems Corp.
Recent clearances by Olympus Medical Systems Corp.
1–100 of 103- K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)
- K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
- K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
- K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
- K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315)
- K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
- K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
- K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
- K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
- K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
- K250701 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
- K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
- K250296 — Disposable Distal Attachment D-201 Series
- K250263 — Disposable Grasping Forceps FG-52D/FG-54D
- K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
- K240617 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
- K221690 — OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
- K221660 — RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
- K221631 — Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
- K221638 — Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
- K220587 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K220069 — 4K UHD LCD Monitor OEV321UH
- K212667 — Single Use Guide Sheath Kit-401, K-402
- K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
- K201300 — Airway Mobilescope
- K201758 — EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
- K200342 — Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L
- K202661 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K203128 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
- K202646 — Visera Elite II Video System Center
- K201920 — Endoscope Reprocessor OER-Elite
- K201200 — Visera Elite II Video System Center
- K192793 — Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
- K200542 — Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
- K192103 — Thunderbeat Open Fine Jaw Type X Hand Instrument
- K192498 — Single Use Injector
- K200397 — Single Use Biopsy Forceps FB-456D
- K193026 — Visera Elite II Video System Center, Visera Elite II Endoeye 3D
- K192164 — Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
- K193182 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V
- K193039 — Single Use Balloon Dilator V (with knife)
- K190239 — Single Use Aspiration Needle
- K190772 — SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
- K183416 — Rhino-Laryngo Videoscope Olympus ENF-VT3
- K183525 — EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
- K183419 — EVIS EXERA III Bronchovideoscope Olympus BF-XT190
- K190449 — Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head
- K190293 — Single Use Cytology Brush BC-205D
- K183590 — Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
- K190969 — ENDOSCOPE REPROCESSOR OER-Elite
- K182408 — Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
- K183053 — Olympus Small Intestinal Capsule Endoscope System
- K182102 — RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
- K181451 — URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
- K173495 — Single Use Hot Biopsy Forceps FD-231
- K180668 — Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
- K181994 — Single Use Aspiration Needle NA-U201H
- K181240 — Rhino-Laryngo Fiberscope Olympus ENF-GP2
- K180575 — THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X
- K180449 — Single Use Aspiration Needle NA-U200H
- K172726 — EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
- K172610 — THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
- K172246 — OLYMPUS URF-V2/V2R
- K172298 — OLYMPUS URF-P6/P6R
- K173459 — Olympus Small Intestinal Capsule Endoscope System
- K172734 — Single Use Electrosurgical Snare SD-400
- K172618 — SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
- K170811 — Single Use Retrieval Nitinol Basket V
- K171158 — Single Use Electrosurgical knife
- K172817 — 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
- K171916 — Single Use Hot Biopsy Forceps FD-231
- K172691 — Ultrasonic Generator
- K163069 — OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
- K153773 — Disposal Lens Cleaning Sheath
- K160098 — Single Use Aspiration Needle NA-U401SX
- K160241 — Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
- K151743 — THUNDERBEAT Open Fine Jaw
- K153625 — Single Use Injector NM600/610
- K143153 — EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
- K151738 — Single Use Aspiration Needle NA-U200H
- K150142 — Single Use Balloon Dilator V (with Knife)
- K151011 — VISERA 4K UHD SYSTEM
- K143303 — Single Use Biliary Balloon Dilator
- K142680 — ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT
- K132703 — THUNDERBEAT
- K134026 — ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT
- K131780 — EVIS EXERA III VIDEO SYSTEM
- K123421 — OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
- K123601 — SINGLE USE REPOSITIONABLE CLIP
- K122505 — SINGLE USE PRELOADED SPHINCTEROTOME V
- K123365 — OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
- K130058 — ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
- K123704 — AUTOMATED ENDOSCOPE LEAK TESTER
- K121959 — EVIS EXERA III VIDEO SYSTEM
- K120357 — ENDOSCOPE REPROCESSOR OER-MINI
- K122831 — VIDEO SYSTEM CENTER
- K121564 — ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
- K113120 — CHF-Y0005
- K120278 — WIRELESS IMAGE TRANSMITTER UNIT
- K121701 — SYSTEMS INTEGRATION
Data sourced from openFDA. This site is unofficial and independent of the FDA.