FDA 510(k)

OLYMPUS URF-P6/P6R

K-Number: K172298 · 2018-03-29

Decision Date2018-03-29

Product CodeFGB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OLYMPUS URF-P6/P6R 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 2018-03-29 under 510(k) number K172298. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS URF-P6/P6R?

OLYMPUS URF-P6/P6R is a medical device that received FDA 510(k) clearance on 2018-03-29. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K172298.

When did OLYMPUS URF-P6/P6R receive FDA 510(k) clearance?

OLYMPUS URF-P6/P6R received FDA 510(k) clearance on 2018-03-29, under 510(k) number K172298.

Who is the listed applicant for OLYMPUS URF-P6/P6R?

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 OLYMPUS URF-P6/P6R?

The FDA product code for OLYMPUS URF-P6/P6R is FGB.

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Other records listing Olympus Medical Systems Corp. as applicant

K2620794K Camera Head OLYMPUS CH-S700-08-LB 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)K260580Single 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)K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)

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Related Devices (Code: FGB)

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Official Source

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