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. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.5570. 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..
| 510(k) Number | K211121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |