K212033 is an FDA 510(k) clearance for the Disposable Sterile Syringe, with/without needle. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Shandong Zhushi Pharmaceutical Group Co., Ltd. (Heze, CN). The FDA issued a Cleared decision on August 17, 2022, 414 days after receiving the submission on June 29, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K212033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2021 |
| Decision Date | August 17, 2022 |
| Days to Decision | 414 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 |