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FDA 510(k)

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F

K-Number: K183525 · 2019-09-06

ApplicantOlympus Medical Systems Corp.
Decision Date2019-09-06
Product CodePSV
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F 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 2019-09-06 under 510(k) number K183525. The device is classified under product code PSV. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F?

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K183525.

When did EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F receive FDA 510(k) clearance?

EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F received FDA 510(k) clearance on 2019-09-06, under 510(k) number K183525.

Who is the listed applicant for EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F?

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 EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F?

The FDA product code for EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F is PSV.

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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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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