510(k) K211121
K211121 is an FDA 510(k) premarket notification submitted by Intera Oncology, Inc. for the device "Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit". The FDA issued a decision of Substantially Equivalent on October 14, 2021. The device falls under product code PTI (Non-Coring (Huber) Needle), a Class II device regulated under 21 CFR 880.5570. Intera Oncology, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 2021
- Date Received
- April 15, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Non-Coring (Huber) Needle
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
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.