K232950 is an FDA 510(k) clearance for the Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Perfect Medical Industry (Vn) Co., Ltd. (Ho Chi Minh City, VN). The FDA issued a Cleared decision on June 12, 2024, 266 days after receiving the submission on September 20, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K232950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2023 |
| Decision Date | June 12, 2024 |
| Days to Decision | 266 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 |