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FDA 510(k)

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

K-Number: K220587 · 2022-05-11

ApplicantOlympus Medical Systems Corp.
Decision Date2022-05-11
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Evis Exera III Duodenovideoscope Olympus TJF-Q190V is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2022-05-11 under 510(k) number K220587. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Evis Exera III Duodenovideoscope Olympus TJF-Q190V?

Evis Exera III Duodenovideoscope Olympus TJF-Q190V is a medical device that received FDA 510(k) clearance on 2022-05-11. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K220587.

When did Evis Exera III Duodenovideoscope Olympus TJF-Q190V receive FDA 510(k) clearance?

Evis Exera III Duodenovideoscope Olympus TJF-Q190V received FDA 510(k) clearance on 2022-05-11, under 510(k) number K220587.

Who is the listed applicant for Evis Exera III Duodenovideoscope Olympus TJF-Q190V?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evis Exera III Duodenovideoscope Olympus TJF-Q190V?

The FDA product code for Evis Exera III Duodenovideoscope Olympus TJF-Q190V is FDT.

Other records listing Olympus Medical Systems Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K254056THUNDERBEAT 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)K261260HD Camera Head OLYMPUS CH-S200-08-LBK260580Single 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)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Related Devices (Code: FDT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000Fujifilm CorporationK253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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