FDA 510(k)

TRINITY/3D PROSTATE SUITE

K-Number: K170521 · 2017-05-30

ApplicantKoelis

Decision Date2017-05-30

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TRINITY/3D PROSTATE SUITE is the device name listed in this FDA 510(k) record. The listed applicant is Koelis. It received FDA 510(k) clearance on 2017-05-30 under 510(k) number K170521. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRINITY/3D PROSTATE SUITE?

TRINITY/3D PROSTATE SUITE is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is Koelis. The 510(k) number is K170521.

When did TRINITY/3D PROSTATE SUITE receive FDA 510(k) clearance?

TRINITY/3D PROSTATE SUITE received FDA 510(k) clearance on 2017-05-30, under 510(k) number K170521.

Who is the listed applicant for TRINITY/3D PROSTATE SUITE?

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

What is the FDA product code for TRINITY/3D PROSTATE SUITE?

The FDA product code for TRINITY/3D PROSTATE SUITE is IYN.

Other records listing Koelis 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.

K180970Disposable guides KDNG00 K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range K160357TRINITY

Related Devices (Code: IYN)

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.