K170897 is an FDA 510(k) clearance for the Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site. This device is classified as a Non-coring (huber) Needle (Class II - Special Controls, product code PTI).
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 3, 2017, 221 days after receiving the submission on March 27, 2017.
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 | K170897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2017 |
| Decision Date | November 03, 2017 |
| Days to Decision | 221 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. |