Olympus Medical Systems Corp. FDA Approvals

0 new drug approvals and 27 device clearances on file. Matched by name to OLYMY.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
4K Camera Head OLYMPUS CH-S700-08-LB510(k)Sep 10, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 10, 2026
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)510(k)Jul 1, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 1, 2026
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)510(k)May 21, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 21, 2026
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)510(k)Apr 23, 2026Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Apr 23, 2026
Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR510(k)Mar 6, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 6, 2026
Single Use Distal Cover MAJ-2315 (MAJ-2315)510(k)Feb 22, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Feb 22, 2026
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)510(k)Nov 12, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 12, 2025
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)510(k)Oct 24, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 24, 2025
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)510(k)Oct 17, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 17, 2025
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)510(k)Sep 19, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Sep 19, 2025
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)510(k)Jun 23, 2025Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jun 23, 2025
Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)510(k)Jun 5, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 5, 2025
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M510(k)May 27, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 27, 2025
Disposable Distal Attachment D-201 Series510(k)May 1, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 1, 2025
Disposable Grasping Forceps FG-52D/FG-54D510(k)Mar 31, 2025Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Mar 31, 2025
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P510(k)Mar 18, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 18, 2025
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)510(k)Jun 3, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 3, 2024
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)510(k)Dec 29, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Dec 29, 2022
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP510(k)Dec 28, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Dec 28, 2022
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V510(k)Sep 26, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Sep 26, 2022
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3510(k)Sep 19, 2022Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Sep 19, 2022
Evis Exera III Duodenovideoscope Olympus TJF-Q190V510(k)May 11, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 11, 2022
4K UHD LCD Monitor OEV321UH510(k)Mar 9, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 9, 2022
Single Use Guide Sheath Kit-401, K-402510(k)Sep 22, 2021Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Special)	Sep 22, 2021
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5510(k)Sep 17, 2021Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Sep 17, 2021
Airway Mobilescope510(k)Jan 26, 2021Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jan 26, 2021
EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190510(k)Jan 21, 2021Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jan 21, 2021

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