FDA 510(k)

TRINITY

K-Number: K160357 · 2016-05-02

ApplicantKoelis

Decision Date2016-05-02

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TRINITY is the device name listed in this FDA 510(k) record. The listed applicant is Koelis. It received FDA 510(k) clearance on 2016-05-02 under 510(k) number K160357. 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?

TRINITY is a medical device that received FDA 510(k) clearance on 2016-05-02. The listed applicant is Koelis. The 510(k) number is K160357.

When did TRINITY receive FDA 510(k) clearance?

TRINITY received FDA 510(k) clearance on 2016-05-02, under 510(k) number K160357.

Who is the listed applicant for TRINITY?

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?

The FDA product code for TRINITY 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 K170521TRINITY/3D PROSTATE SUITE

Related Devices (Code: IYN)

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.