FDA 510(k)

GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER

K-Number: K132181 · 2013-10-21

ApplicantOlympus Surgical Technologies America

Decision Date2013-10-21

Product CodeEZN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2013-10-21 under 510(k) number K132181. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER?

GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 2013-10-21. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K132181.

When did GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER receive FDA 510(k) clearance?

GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER received FDA 510(k) clearance on 2013-10-21, under 510(k) number K132181.

Who is the listed applicant for GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER?

The FDA 510(k) record lists Olympus Surgical Technologies America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER?

The FDA product code for GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER is EZN.

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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.