FDA 510(k)

Bi-Flex Evo

K-Number: K182144 · 2018-09-07

Decision Date2018-09-07

Product CodeKNY

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Bi-Flex Evo is the device name listed in this FDA 510(k) record. The listed applicant is Promepla Sam. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K182144. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bi-Flex Evo?

Bi-Flex Evo is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Promepla Sam. The 510(k) number is K182144.

When did Bi-Flex Evo receive FDA 510(k) clearance?

Bi-Flex Evo received FDA 510(k) clearance on 2018-09-07, under 510(k) number K182144.

Who is the listed applicant for Bi-Flex Evo?

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

What is the FDA product code for Bi-Flex Evo?

The FDA product code for Bi-Flex Evo is KNY.

Other records listing Promepla Sam 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.

K173734RocaJJ Soft Stents K152278ENDOFLOW II - Irrigation, Warming and Suction System

Related Devices (Code: KNY)

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K162356Vesair Cystoscopic SheathSolace Therapeutics

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.