PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)— 510(k) K252098

Substantially Equivalent

Methyl Co., Ltd.

FDA 510(k) clearance K252098 for PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED), Substantially Equivalent on 2026-02-18. Applicant: Methyl Co., Ltd..

Clearance details

Applicant: Methyl Co., Ltd.
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2025-07-03
Decision date: 2026-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.