ClearLine IV
K-Number: K171954 · 2018-01-25
ApplicantClearline MD
Decision Date2018-01-25
Product CodeOKL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
ClearLine IV is the device name listed in this FDA 510(k) record. The listed applicant is Clearline MD. It received FDA 510(k) clearance on 2018-01-25 under 510(k) number K171954. The device is classified under product code OKL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ClearLine IV?
ClearLine IV is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is Clearline MD. The 510(k) number is K171954.
When did ClearLine IV receive FDA 510(k) clearance?
ClearLine IV received FDA 510(k) clearance on 2018-01-25, under 510(k) number K171954.
Who is the listed applicant for ClearLine IV?
The FDA 510(k) record lists Clearline MD as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ClearLine IV?
The FDA product code for ClearLine IV is OKL.
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.