Cleared Traditional

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit

K211121 · Intera Oncology, Inc. · General Hospital

Oct 2021

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K211121 is an FDA 510(k) clearance for the Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit, a Non-coring (huber) Needle (Class II — Special Controls, product code PTI), submitted by Intera Oncology, Inc. (Wellesley, US). The FDA issued a Cleared decision on October 14, 2021, 182 days after receiving the submission on April 15, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K211121 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 2021
Decision Date	October 14, 2021
Days to Decision	182 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PTI — Non-coring (huber) Needle
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5570
Definition	The Non-coring Needle (huber) Is Utilized To Gain Access Into A Subcutaneous Implanted Intravascular Infusion Port But Can Also Be Used To Access Other Non-vascular Implanted Devices With Similar Septums.