Sinusway Dilation System

FDA 510(k) K181838 · 3nt Medical , Ltd.

Substantially Equivalent

510(k) numberK181838

Submission

Device name
Sinusway Dilation System
Applicant
3nt Medical , Ltd.
Rosh Ha'Ayin, IL
Received
July 10, 2018
Decision date
December 20, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LRC – Instrument, Ent Manual Surgical
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Specialty
Ear, Nose, Throat

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Questions and answers

When was Sinusway Dilation System cleared by the FDA?

Sinusway Dilation System (K181838) received a 510(k) decision of Substantially Equivalent on December 20, 2018, 163 days after the submission was received.

What is the product code of K181838?

The FDA product code is LRC – Instrument, Ent Manual Surgical, a Class I (low risk) device regulated under 21 CFR 874.4420.