Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit— 510(k) K211121

Name: FDA 510(k) clearance K211121
Creator: U.S. Food and Drug Administration
Published: 2021-10-14

Substantially Equivalent

Intera Oncology, Inc.

FDA 510(k) clearance K211121 for Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit, Substantially Equivalent on 2021-10-14. Applicant: Intera Oncology, Inc.. Device class: 2.

Clearance details

Applicant: Intera Oncology, Inc.
Product code: Code PTI
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2021-04-15
Decision date: 2021-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, MA, US

Download summary PDF View on FDA.gov ↗

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