K170651 is an FDA 510(k) clearance for the Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Yangzhou Medline Industry, Co., Ltd. (Yangzhou, CN). The FDA issued a Cleared decision on August 2, 2017, 152 days after receiving the submission on March 3, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K170651 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2017 |
| Decision Date | August 02, 2017 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |