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FDA 510(k)

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

K-Number: K211121 · 2021-10-14

ApplicantIntera Oncology, Inc.
Decision Date2021-10-14
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit is a medical device manufactured by Intera Oncology, Inc.. It received FDA 510(k) clearance on 2021-10-14 under approval number K211121. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit is a medical device that received FDA 510(k) clearance on 2021-10-14. It is manufactured by Intera Oncology, Inc.. The 510(k) number is K211121.

When was Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit approved by the FDA?

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit received FDA 510(k) clearance on 2021-10-14, under approval number K211121.

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

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit is manufactured by Intera Oncology, Inc..

What is the FDA product code for Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit?

The FDA product code for Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit is PTI.

Related Clinical Trials

NCT03228641 Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity COMPLETED

Other Devices by Intera Oncology, Inc.

K213823Intera Refill Kit

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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