FDA 510(k)

EVIS EXERA III VIDEO SYSTEM

K-Number: K131780 · 2013-08-29

Decision Date2013-08-29

Product CodeFDF

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EVIS EXERA III VIDEO SYSTEM 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 2013-08-29 under 510(k) number K131780. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVIS EXERA III VIDEO SYSTEM?

EVIS EXERA III VIDEO SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-29. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K131780.

When did EVIS EXERA III VIDEO SYSTEM receive FDA 510(k) clearance?

EVIS EXERA III VIDEO SYSTEM received FDA 510(k) clearance on 2013-08-29, under 510(k) number K131780.

Who is the listed applicant for EVIS EXERA III VIDEO SYSTEM?

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 VIDEO SYSTEM?

The FDA product code for EVIS EXERA III VIDEO SYSTEM is FDF.

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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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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.