K191642 is an FDA 510(k) clearance for the TK Sterile Piston Syringe without Needle. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on January 6, 2020, 201 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 | K191642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2019 |
| Decision Date | January 06, 2020 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |