Cleared Traditional

Orbit Inserter

K163400 · Ypsomed AG · General Hospital
Jul 2017
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K163400 is an FDA 510(k) clearance for the Orbit Inserter, a Introducer, Syringe Needle (Class II — Special Controls, product code KZH), submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on July 26, 2017, 233 days after receiving the submission on December 5, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6920.

Submission Details

510(k) Number K163400 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2016
Decision Date July 26, 2017
Days to Decision 233 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZH — Introducer, Syringe Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6920