K191639 is an FDA 510(k) clearance for the TK Insulin Syringe with/without Saftey Retractable Device. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on September 11, 2020, 450 days after receiving the submission on June 19, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K191639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2019 |
| Decision Date | September 11, 2020 |
| Days to Decision | 450 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 |