Cleared Special

Intera Refill Kit

K213823 · Intera Oncology, Inc. · General Hospital

Mar 2022

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K213823 is an FDA 510(k) clearance for the Intera Refill 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 March 16, 2022, 98 days after receiving the submission on December 8, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K213823 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 2021
Decision Date	March 16, 2022
Days to Decision	98 days
Submission Type	Special
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.