K163437 is an FDA 510(k) clearance for the hypodermic Pinpoint™ GT Needle. This device is classified as a Non-stainless Steel Needle (Class II - Special Controls, product code PVZ).
Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on June 23, 2017, 198 days after receiving the submission on December 7, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570. A Hypodermic Needle Is Intended To Inject Medication And Aspirate Fluid, Below The Surface Of The Skin. Designed To Be Used With Ultrasound For Better Visualization Of Needle During Use..
| 510(k) Number | K163437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2016 |
| Decision Date | June 23, 2017 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PVZ — Non-stainless Steel Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
| Definition | A Hypodermic Needle Is Intended To Inject Medication And Aspirate Fluid, Below The Surface Of The Skin. Designed To Be Used With Ultrasound For Better Visualization Of Needle During Use. |