K252098 is an FDA 510(k) clearance for the PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED). This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Methyl Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on February 18, 2026, 230 days after receiving the submission on July 3, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K252098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2025 |
| Decision Date | February 18, 2026 |
| Days to Decision | 230 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 |