PTI — Non-Coring (Huber) Needle Class II
FDA product code PTI covers "Non-Coring (Huber) Needle", a Class II medical device regulated under 21 CFR 880.5570. Submissions are reviewed by the General Hospital panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PTI
- Device Class
- Class II
- Regulation Number
- 880.5570
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252355 | sb-kawasumi laboratories | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing | November 26, 2025 |
| K251138 | promisemed hangzhou meditech co | Promisemed Safety Huber Needles | May 13, 2025 |
| K243332 | promisemed hangzhou meditech co | Promisemed Safety Huber Needles | March 14, 2025 |
| K241353 | bard access systems | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set | November 27, 2024 |
| K230715 | promisemed hangzhou meditech co | Promisemed Safety Huber Needle | June 8, 2023 |
| K213823 | intera oncology | Intera Refill Kit | March 16, 2022 |
| K211121 | intera oncology | Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolu | October 14, 2021 |
| K200463 | jiangsu caina medical co | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | April 7, 2021 |
| K170881 | infusion safety products | ISP Safety Huber Needle Infusion Set | December 14, 2017 |
| K170897 | b.braun medical | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle wit | November 3, 2017 |
| K171735 | c.r. bard | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | August 8, 2017 |
| K171333 | medcomp (dba medical components, inc.) | 20G x 5/8 Pro-Lock CT Safety Infusion Set | July 18, 2017 |
| K162271 | medcomp (medical components, inc.) | Pro-Lock CT Safety Infusion Set | April 26, 2017 |